News Makary, Prasad set out their vision for the FDA Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency."
News Dismay as RFK Jr ousts CDC vaccine advisors RFK Jr has removed all 17 members of the CDC's vaccine advisory committee in a move that some fear could lead to restrictions on immunisation access.
News Wockhardt has high hopes for novel antibiotic Zaynich Wockhardt has completed a pre-filing meeting with the FDA and is preparing to submit its novel antibiotic Zaynich in the US and Europe.
News EU: Trials should include pregnant subjects where possible With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.
News Amid staff cuts, FDA looks to AI to 'optimise' reviews The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.
News Axe falls on Stealth Bio staff after FDA rejects lead drug Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.
Oncology BioNTech’s ASCO 2025 oncology advances: New data on bispecif... At ASCO 2025, BioNTech presented 7 abstracts on four selected pipeline candidates in mesothelioma, lung cancer, prostate cancer, and melanoma.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face
