FDA authorises second booster of Pfizer/BioNTech and Moderna COVID shots
The agency said the new boosters - a fourth round of shots for most vaccine recipients - of the Pfizer Inc/BioNTech SE and Moderna…
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US FDA approval
US FDA approves Novo Nordisk’s Ozempic 2 mg to treat type-II diabetes
Ozempic demonstrated 2.1 per cent blood sugar reduction and also weight loss in adults with type-II diabetes with new 2 mg dose
US FDA grants Breakthrough Therapy Designation to Pfizer’s Respiratory Syncytial Virus vaccine…
The decision is primarily informed by the positive results of a proof-of-concept, phase IIa study evaluating the safety,…
Indoco Remedies gets final nod from US FDA for Lacosamide tablet
The approval granted by the US Food and Drug Administration (FDA) for Lacosamide tablets is for strengths of 50 mg, 100 mg, 150 mg…
Alembic Pharma receives US FDA final approval for Lacosamide tablets
Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
US FDA approves new Bristol Myers cancer immunotherapy
The company said it expects the treatment to eventually garner annual sales of more than $4 billion
Zydus receives PAS approval from US FDA for Mycophenolate Mofetil for injection
The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat
FDA approves first generic of Symbicort to treat asthma and COPD
Agency supports development of complex generic drug-device combination product to improve competition and access to more…
Zydus receives final approval from US FDA for Colestipol Hydrochloride tablets
Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C…
Alembic Pharmaceuticals receives US FDA tentative approval for Macitentan tablets, 10 mg
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of…