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 ...

USFDA issued a warning letter to Glenmark Pharmaceuticals for significant CGMP violations at its Pithampur plant, including failing to establish laboratory controls and adequate testing programs.

Osaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHub and HyHub ...

The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated’ (VAI) and has officially closed the ...

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

The company is going to announce results for the quarter ended June 30th, 2025 on July 23, 2025 after the board meeting.

A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...

Dr. Reddy's Laboratories receives a Form 483 with seven observations from the USFDA after an inspection of its Srikakulam ...

Cipla to acquire 20% in iCaltech, Eraaya reviews FCCB terms, and Dr Reddy’s API plant in New York receives VAI status from USFDA after GMP inspection.

The USFDA said it inspected the manufacturing facility from April 15 to 23, 2024. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations ...

The USFDA says diced onions used at McDonald’s have not been linked to the E. coli outbreak. Investigators believed they have narrowed their focus to slivered onions only.

Approved Study to Examine Tolerability of MDMA in Schizophrenia at UCLA VANCOUVER, British Columbia, June 09, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA ...