News

OpenAI and the FDA Are Holding Talks About Using AI In Drug Evaluation
High-ranking OpenAI employees have met with the FDA multiple times in recent weeks to discuss AI and a project called cderGPT ...
American Hospital Association2d
FDA commissioner talks of shortening drug approval process, benefits of AI
Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...
JD Supra7d
Conditional Approval Proposals for FDA: Current Context and Potential Ramifications
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...
FDA, OpenAI discussing use of AI for drug evaluation
The FDA is looking into how AI could help with final drug approvals and improve internal tasks like checking whether an ...
STAT11d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...
STAT15m
FDA approves Verastem’s ovarian cancer treatment
Matthew Herper joins Adam and Allison to examine Prasad’s appointment and the band of outsiders now in charge of U.S. health ...
Rare Disease Industry Awaits FDA Chief’s New Drug Pathway Plan
FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease ...
Fierce Pharma19h
FDA misses another approval decision target date, this time for GSK's Nucala in COPD
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 ...
US FDA centers to deploy AI internally, following experimental run
The U.S. Food and Drug Administration said on Thursday all its centers will deploy artificial intelligence internally ...
Exclusive: US FDA asks some fired pharma user fee negotiation staff to return
The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding ...
Fierce Biotech9d
UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again
An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...
Oncology Nursing News19h
Avutometinib/Defactinib Earns FDA Accelerated Approval for KRAS+ LGSOC
The FDA has granted accelerated approval to avutometinib (VS-6766) plus defactinib (VS-6063) for the treatment of adult ...