USFDA

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Brekiya dihydroergotamine mesylate injection, the first and only dihydroergotamine autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The U.S. Food and Drug Administration inspected Aspen Biopharma Labs Private Limited, drug facility; at Rangareddy region from September 16 to September 21, 2024. And they get a warning letter which summarizes significant deviations from Current Good Manufacturing Practice CGMP for active pharmaceutical ingredients.

Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio.

Novartis announced that oral Fabhalta iptacopan has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition.

Zydus Life sciences Limited has received final approval from the United States Food and Drug Administration USFDA to manufacture Apalutamide Tablets, 60 mg.

Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application for Opdivo nivolumab plus Yervoy ipilimumab as a potential first-line treatment option for adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high MSI-H or mismatch repair deficient dMMR colorectal cancer