A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

FDA will implement a secure generative AI system across all centers by June 30, aiming to streamline internal reviews and ...

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...

Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...

The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. | GSK had expected to secure an FDA ...

The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding ...

Treatment with the Avmapki Fakzynja Co-pack received accelerated FDA approval for previously treated low-grade serous ovarian ...

The FDA has granted accelerated approval to avutometinib (VS-6766) plus defactinib (VS-6063) for the treatment of adult ...