http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Fri, 19 Jun 2026 06:31:28 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html <p>Japan's Ministry of Health, Labour and Welfare has approved Sanofi's (EURONEXT: SAN, NASDAQ: SNY) subcutaneous formulation of Sarclisa (isatuximab) for the treatment of multiple myeloma, the company said in a press release dated June 19, 2026.</p> <p>The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma in adult patients.</p> <p>The decision is based primarily on results from the IRAKLIA phase 3 study (NCT05405166), which evaluated Sarclisa SC administered via an on-body injector (OBI) against the intravenous formulation http://www.streetinsider.com/FDA/Sanofi+wins+Japan+approval+for+Sarclisa+SC+in+multiple+myeloma/26668010.html Fri, 19 Jun 2026 06:31:28 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Press+Releases/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html <p><i>Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma</i></p> <ul type="disc"><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Approval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IV</li><li style="margin-top:3pt; margin-bottom:3pt; text-align:justify;">Second global approval for Sarclisa SC following the EU</li></ul> <p align="justify"><b>Paris, June 19, 2026. </b>The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide http://www.streetinsider.com/Globe+Newswire/Press+Release%3A+Sanofi%E2%80%99s+Sarclisa+subcutaneous+formulation+approved+in+Japan+for+patients+with+multiple+myeloma/26668009.html Fri, 19 Jun 2026 06:31:00 -0400 A.05963196 A.22211465 A.50216924 O.00356206 O.05375760 O.25005674 O.54450828 SAN SNY