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- FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
- Cullinan-Taiho eye FDA filing for zipalertinib after trial shows strong PFS benefit despite three deathsCullinan Therapeutics and its partner Taiho Oncology said they will seek FDA approval for zipalertinib, an oral therapy for a subset of non‑small cell lung cancer, based on data from a late‑stage s…