Amphastar Pharmaceuticals, Inc.,announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate...
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance...
BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab,...
Curium announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used...
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals. BioXcel Therapeutics, based in New Haven, Conn., has a target action date...
The world’s first “human challenge” trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others. The findings underscore the...
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