FDA publishes a guidance for using bioburden reduction systems with dry heat to reuse certain filtering facepiece respirators.
FDA defers its review decision on a Revance Therapeutics BLA for daxibotulinumtoxinA for injection, an investigational neuromodulator for treating mod...
Purdue Pharma pleads guilty to three felony counts as part of a plea agreement announced in October.
Merck submits a BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and older.
Three Covington & Burling attorneys analyze how a Biden administration may make its mark on FDA Centers and programs.
Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a person that has an appro...
An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pulmonary arterial hyp...
FDA senior trade advisors outline reasons why the new U.S.-Mexico-Canada agreement is better for the agency and public health than the North American ...