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Three stakeholders make suggestions to an FDA draft guidance on efficacy endpoints in clinical trials for antidiabetic drugs.[ Price : $8.95]
Lilly says its Retevmo met the primary progression-free survival endpoint in a clinical trial in patients with RET-mutant medullar...[ Price : $8.95]
FDA clears a Welldoc 510(k) for its BlueStar diabetes digital health device that provides bolus insulin dose recommendations based...[ Price : $8.95]
FDA grants Nexcella an orphan drug designation for its CAR-T cell therapy NXC-201 for treating multiple myeloma.[ Price : $8.95]
FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.[ Price : $8.95]
FDA warns Walmart and Amazon they are illegally distributing unapproved new drugs to treat molluscum contagiosum.[ Price : $8.95]
FDA warns Noblesville, IN-based Ambu, Inc., that it is illegally distributing an unapproved medical device.[ Price : $8.95]
FDA lifts a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease.