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Federal Register notice: FDA determines that 18 drug products listed in the notice were not withdrawn from sale due to safety or effectiveness concern...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.
A bipartisan group of U.S. Senators and House members call on FDA to step up its regulatory activities to improve rare disease product development and...
FDA approves Astellas Pharmas Veozah (fezolinetant), an oral drug for treating moderate-to-severe vasomotor symptoms caused by menopause.
Due to its authority having expired on 5/11 with the end of the Covid-10 public health emergency (PHE), FDA now urges medical device makers to maintai...
FDAs Pulmonary-Allergy Drug Advisory Committee votes to recommend approval for ARS Pharmaceuticals neffy (epinephrine) nasal spray for treating severe...
