Mumbai-based pharma firm Wockhardt announced that the United States Food and Drug Administration (USFDA) has accepted its New ...

Lupin receives USFDA approval for generic Siponimod Tablets to treat multiple sclerosis, boosting market presence and ...

Dr Reddy’s Laboratories ( ($RDY) ) just unveiled an update. On December 12, 2025, Dr. Reddy’s Laboratories announced that the United States Food & ...

While drugmakers like Dr. Reddy's Laboratories and Aurobindo Pharma are in focus on the back of the observations issued by ...

A black box warning is the strongest caution for prescription drugs and is usually reserved for alerting patients to possible ...

The company has received approval from the US Food and Drug Administration (USFDA) to market Amantadine extended-release capsules (68.5 mg) and tentative approval for Gocovri (137 mg) capsules, the ...

Khorakiwala said the Mumbai-based drugmaker is already laying groundwork for commercialization, with options ranging from solo marketing to partnerships in the US.

The next critical steps in the USFDA process involve a rigorous on-site evaluation: "visiting manufacturing facilities, inspecting documents, and so on".

Aurobindo Pharma on Wednesday said it has received approval from the US health regulator to market a generic medication for the treatment of human immunodeficiency virus (HIV-1) infection. The company ...

New Delhi: Ahmedabad based Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, ...

This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules, 68.5 mg. (Image Credits: Pixabay) Zydus Lifesciences Limited on Wednesday announced that it has ...

Zydus Lifesciences Ltd on Monday said it has received final approval from the US health regulator to market its generic version of Cyanocobalamin injection which is used to treat and prevent vitamin ...