USFDA

In a landmark development, Gilead Sciences announced today that the U.S. Food and Drug Administration has approved Yeztugo (lenacapavir), the first injectable pre-exposure prophylaxis (PrEP) for HIV prevention requiring just two doses per year.

Glenmark Pharmaceuticals Ltd. has announced that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practices (GMP) inspection at its manufacturing facility in Monroe, North Carolina, USA.

Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte.

Zydus Lifesciences has received the Establishment Inspection Report from the United States Food and Drug Administration for its Active Pharmaceutical Ingredient manufacturing facility located at Dabhasa, near Vadodara, Gujarat.

U.S. Food and Drug Administration approval of a New Drug Application for KHINDIVI hydrocortisone Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency.

GSK plc announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

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.