Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug ...

Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling various drugs in the US due to manufacturing issues and product mix-ups, as reported by the US health regulator.

Sun Pharma recalls Dimesylate capsules, Lupin recalls Lisinopril and Hydrochlorothiazide tablets, and Dr Reddy’s recall ...

Indian pharmaceutical giants Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs from the US market due to ...

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application ...

The Carbamazepine extended-release tablets are indicated for use as an anti-convulsant drug and also for the treatment of the ...

Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small ...

Lupin receives USFDA approval for generic Liraglutide Injection and Glucagon, expanding access to diabetes treatments.

USFDA issued a warning letter to Glenmark Pharmaceuticals for significant CGMP violations at its Pithampur plant, including ...

Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets.

Zydus Lifesciences got USFDA approval for Celecoxib capsules (50–400 mg) to treat arthritis, JIA, and AS. Made in Ahmedabad, ...

The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant.      In a warning letter, the ...