Three stakeholders make suggestions to an FDA draft guidance on efficacy endpoints in clinical trials for antidiabetic drugs.
Lilly says its Retevmo met the primary progression-free survival endpoint in a clinical trial in patients with RET-mutant medullary thyroid cancer.
FDA clears a Welldoc 510(k) for its BlueStar diabetes digital health device that provides bolus insulin dose recommendations based on readings from co...
FDA grants Nexcella an orphan drug designation for its CAR-T cell therapy NXC-201 for treating multiple myeloma.
FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.
Federal Register notice: FDA announces a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for Lumakras (sotorasib)...
The Consumer Healthcare Product Association tells CDRH patient self-diagnosis need not be a requirement for the at-home use of over-the-counter medica...
FDA warns Walmart and Amazon they are illegally distributing unapproved new drugs to treat molluscum contagiosum.
