FDA issues Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresecta...
The U.S. Supreme court decides to not hear a closely watched appeal of a lower courts ruling in a so-called skinny label case won by GlaxoSmithKline a...
FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray for treating severe...
Federal Register notice: FDA publishes its final decision rendered last month to withdraw approval of Covis Pharma Groups Makena (hydroxyprogesterone ...
Federal Register notice: FDA makes available a final guidance entitled Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Qu...
Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or effectiveness concern...
FDA grants Pyxis Oncology an orphan drug designation for PYX-201 in pancreatic cancer.
Rated Class 1 by FDA, Cordis recalls its Angioguard RX/XP Emboli Capture Guidewire System due to device separation concerns.
