- FDA to end pilot aimed at preventing production issuesThe FDA said it will end a pilot that was intended to help drugmakers proactively address production issues. Few companies took advantage of the program during its three-year run. In April 2027,…Endpoints · 4d ago↗ source
- Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbumpAn unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”BioSpace · 4d ago↗ source
- Chutes & Ladders—Biogen R&D vet gets in FormationAI-focused Formation Bio has found a new chief scientist with extensive experience in biotech, Big Pharma and academia. Michael Ehlers, M.D., Ph.D., is joining the 2025 Fierce 15 honoree as chief s…