Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-line maintenance thera...
Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek increased enforcemen...
Federal Register notice: FDA announces the revocation of B. Braun Medical emergency use authorizations for three Covid-related devices.
A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds on existing FDA regul...
Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for treating amyotrophic lat...
CDRH issues an early alert on a Fresenius Kabi high-risk Ivenix large-volume pump issue, the Centers first alert under a new communications pilot prog...
Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.
scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor used with its Furosci...
