Master Protocols SBIA Chronicle
The innovative regulatory approaches resulting from the 21st Century Cures Act are modernizing new drug development. The use of clinical trials with Master Protocol design is one example of a modern approach to expedite the development of oncology drugs and biologics....SHATA TRADERS INC RECALLS CHEF BRAND MILK PAN 24cm BECAUSE OF POSSIBLE HEALTH RISK
Summary Company Announcement Date: November 19, 2025 FDA Publish Date: November 19, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product has the potential to be contaminated with significant levels of lead (Pb) which may...FDA grants traditional approval to daratumumab and hyaluronidase-fihj
On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL)...Questions and Answers: sunscreen deemed final order and proposed order
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. FDA posted the deemed final order for sunscreens which sets the current...FDA grants accelerated approval to sevabertinib
On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC)...All Drug Purchases Are
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