Aurobindo Pharma gets US FDA nod for generic cancer drug Bortezomib
The product is the generic version of Reference Listed Drug (RLD) Velcade of Takeda Pharma
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US FDA approval
Zydus receives final approval from US FDA for Bortezomib for injection
Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma
Alembic Pharma receives US FDA tentative approval for Ivabradine tablets
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Corlanor tablets, 5 mg and…
Zydus Lifesciences receives final approval from US FDA for Cyanocobalamin injection
The injection is used to treat and prevent lack of vitamin B12 that may be caused due to pernicious anaemia, certain diseases,…
Aleor Dermaceuticals receives US FDA final approval for Lidocaine and Prilocaine cream
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product EMLA Cream, 2.5%/2.5%, of Teva Branded…
US FDA approves Gilead cell therapy for earlier lymphoma
The one-time treatment was initially approved in 2017 for patients with large B-cell lymphoma who did not respond to at least two…
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…
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…