As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The U.S. FDA had inspected the API facility, in Mekaguda here, from June 9-13 and issued Form 483 with one observation. The regulator had classified it as “voluntary action indicated” (VAI), the ...

Natco Pharma informed that the U.S. Food and Drug Administration (US FDA) has issued an EIR for its active pharmaceutical ingredient (API) division located in Mekaguda, Hyderabad, Telangana.

It's unclear whether the errors were generated by artificial intelligence. But the mistakes brought to mind the criticism ...

On Thursday, 1644 stocks advanced, 2409 declined and 168 remained unchanged on Bombay Stock Exchange with advance decline ...

Vimta Labs Ltd (BOM:524394) reports robust growth with a 31.4% revenue increase and unveils plans for biologics expansion.

Q2 2025 Earnings Call Transcript July 24, 2025 Labcorp Holdings Inc. misses on earnings expectations. Reported EPS is $2.83 ...

Adding to the unease, trade negotiations between India and the U.S. have reportedly hit a roadblock. With Washingtons August 1 deadline approaching, talks remain stalled over tariff reductions on key ...

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

Indian pharmaceutical companies Sun Pharma, Lupin, and Dr Reddy's Laboratories are conducting recalls in the US due to ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...