The FDA posted to its site the observations made during an inspection of an AstraZeneca (AZN) manufacturing center that was conducted from May 30, 2024 to June 7, 2024, including manufacturing and ...

Zydus Lifesciences Ltd received the “No Observation” from US Food and Drug Administration in its recently concluded surveillance inspection of its API (Active Pharmaceutical Ingredients ...

announced the successful completion of a surprise US Food and Drug Administration (FDA) inspection at its active pharmaceutical ingredient (API) manufacturing facility in Alathur, Tamil Nadu. The ...

Many critical functions of the food division of the Food and Drug Administration have been ... The time lag “is already impacting the inspection force.” Food safety experts in and outside ...

Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...

Blockbuster weight-loss and diabetes drugs Wegovy and Ozempic are no longer in shortage, the US Food and Drug Administration said on Friday. The update about the popular semaglutide injections ...

President Donald Trump’s pick to lead the US Food and Drug Administration told senators in a tense confirmation hearing Thursday that, if confirmed as FDA commissioner, he plans to evaluate ...

The Food and Drug Administration approved Ctexli for the treatment of cerebrotendinous xanthomatosis in adults. “Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage ...

Cohen, whose leadership of meme stock favorite GameStop has made him an icon among retail traders, has been steadily adding to his position in Alibaba in recent months. His stake in the company ...

The meme coin trade has morphed into something bizarre. Even for the uninitiated, the once-obscure corner of the crypto market has become hard to ignore. Often with no actual use case and values ...

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. With a large backlog, we’re anticipating a significant ramping up of inspections in different ...

Exclusive-US FDA Asks Fired Scientists to Return, Including Some Reviewing Musk’s Neuralink By Patrick Wingrove, Rachael Levy, Michael Erman (Reuters) -The U.S. Food and Drug Administration is ...