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

On May 8, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib for ...

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

Matthew Herper joins Adam and Allison to examine Prasad’s appointment and the band of outsiders now in charge of U.S. health ...

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

Dyne participated in a Type C meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in May 2025 and discussed the path to regulatory approval, ...

The FDA's decision to appoint Vinay Prasad, MD, MPH, to head its Center for Biologics Evaluation and Research (CBER) raised ...

A "productive" meeting with the FDA has given the firm confidence in its regulatory filing and commercialization plans for ST-920.

Denali Therapeutics DNLI reported a first-quarter 2025 loss of 78 cents per share, wider than the Zacks Consensus Estimate of ...

The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop ...

Imagine being told there’s a drug that might save your life — but your insurance won’t cover it for 18 months. That’s the ...

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