FDA steps up its review of phosphatidylinositol-3-kinase (PI3K) inhibitor safety concerns by convening a 4/21-22 Oncologic Drugs Advisory Committee me...
Federal Register notice: FDA creates a docket to receive comments on changes to the agencys previously proposed quality metrics reporting program.
The Regulatory Affairs Professional Society says FDA and medical device industry representatives have reached an agreement on MDUFA 5.
FDA clears a Cionic 510(k) for its lightweight leg-worn Cionic Neural Sleeve, intended for functional electrical stimulation to assist in gait for peo...
Hogan Lovells hires former FDAer Ryan Foringer as a senior regulatory specialist.
House and Senate appropriators come to terms to give FDA a $102 million (3.2%) boost to its discretionary funding for fiscal year 2022 operations.
Sanofi and partner Swedish Orphan Biovitrum plan FDA submission after announcing positive topline results from the pivotal XTEND-1 Phase 3 study evalu...
FDA warns College Station, TX-based CardioQuip about multiple violations in its manufacture of a cardiac heater-cooler device in various configuration...