Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Neurocrine Biosciences Orilissa (elagolix sodiu...
Federal Register notice: FDA seeks comments on an information collection revision entitled General Drug Labeling Provisions and OTC Monograph Drug Use...
The Union of Concerned Scientists says it will be asking scientists in seven federal agencies to describe the state of science in their agencies under...
FDA says its monitoring of breast implants has detected some cases of squamous cell carcinoma and various lymphomas in the scar tissue around the impl...
FDA publishes an immediately effective guidance on emergency use authorizations for monkeypox diagnostic tests.
Indias Panacea Biotec says it is working with FDA to close a recent inspection that had eight observations and an Official Action Indicated classifica...
FDA issues a safety alert to warn about potential clip lock malfunctions with Abbotts MitraClip Delivery Systems.
FDA approves a Revance Therapeutics BLA for injectable Daxxify (daxibotulinumtoxinA-lanm) for temporarily improving moderate-to-severe frown lines.
