The U.S. Government Accountability Office writes HHS about the need for FDA to make it a high priority to act on inspection-related recommendations th...
U.S. Senators Jacky Rosen (D-NV) and Todd Young (R-IN) introduce their bipartisan Strengthening Cybersecurity for Medical Devices Act that would manda...
FDA extends the review of an Amylyx Pharmaceuticals NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), for treating amyotrophic lateral scleros...
FDA says it has approved a new dermal handpiece for the Apyx Renuvion/J-Plasma.
FDA releases the FDA-483 with five observations from an inspection at Tulsa, OK-based CFP Acquisitions, a sterile drug producer.
Three Goodwin Procter attorneys describe safeguards that keep a physician-owned distributor of a medical device from facing anti-kickback sanctions.
Gamida Cell completes a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant.
Centessa Pharmaceuticals discontinues its development of lixivaptan for autosomal dominant polycystic kidney disease after due to a questionable safet...