Trodelvy Approved in Europe for Hard-to-Treat Breast Cancer Patients
The European Commission has granted marketing authorization for Trodelvy® (sacituzumabgovitecan) as an initial treatment for adults with unresectable or metastatic triple-negative breast cancer (mTNBC) who are ineligible...
Maiva Pharma launches brand-new, 22-acre sterile injectables plant in Tamil Nadu
Maiva Pharma Private Limited, a leading US FDA-approved sterile injectables manufacturer, has officially inaugurated its brand-new manufacturing plant. Spanning a sprawling 22-acre campus in Shoolagiri, Tamil Nadu, the...
EU approved Sanofi’s Cenrifki as first disability-taegeting medicine for SPMS
Sanofi announced that the European Commission has approved Cenrifki (tolebrutinib), marking a historic milestone as the first and only therapy authorized in the European Union specifically...
FDA Approves Utebzi for Complicated Urinary Tract Infections
GSK plc and Spero Therapeutics announced that the US Food and Drug Administration (FDA) has approved Utebzi(tebipenem pivoxil). It is indicated for adult patients with complicated urinary tract...
Lupin Introduces Azilsartan Medoxomil Tablets in the United States
Lupin Limited (Lupin) the Indian Global pharmaceuticals major announced that the company will launch Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States, which got approval from the U.S. byAbbreviated New Drug Application (ANDA).
This is a bioequivalent product of Edarbi® produces byAzurity Pharmaceuticals,...
FDA Grants Accelerated Approval to Sanofi’s Tzield® for Pediatric Stage 3 Type 1 Diabetes
The U.S. Food and Drug Administration has granted accelerated approval to Sanofi's Tzield® (teplizumab-mzwv) for children aged 8 to 17 years recently diagnosed with stage...
