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- Kelun’s Merck-partnered ADC notches late-stage NSCLC win alongside KeytrudaThe Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Par…BioSpace · 16d ago↗ source
- Diamantas backtracks on Makary’s policies issued in journal articlesThe acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…raps · 17d ago↗ source
- Experts: Industry to benefit from focused follow-ups, major deficiency letters in MDUFA VIIndustry experts say the draft commitment letter for the next Medical Device User Fee Amendments (MDUFA VI) program negotiated by the US Food and Drug Administration (FDA) and the medtech industry…