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Novartis announced that its radioligand chemotherapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) extended progression-free survival in men with previously treated prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Read More
Reducing the collection of safety data in late-stage and postapproval clinical trials can improve trial efficiency, the FDA says in a final guidance published on Monday. Read More
President Biden has signed into law a bill that creates a new registration process for carrying out marijuana-related research and for facilitating the development and manufacturing of marijuana-based drugs. Read More
The FDA should take a page out of one online retail giant’s book, says Commissioner Robert Califf, as it works to update its technology infrastructure and make its processes and interactions with industry as efficient as possible. Read More
Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that. Read More
Johnson & Johnson (J&J) has sued Amgen for allegedly violating its patent protections for blockbuster Stelara (ustekinumab) — a biologic FDA-approved for treating ulcerative colitis, psoriatic arthritis, plaque psoriasis and Crohn’s disease, among other indications. Read More