Federal Register notice: FDA announces a 4/17 Antimicrobial Drugs Advisory Committee meeting to discuss an Entasis Therapeutics NDA for sulbactam-durl...
A new Government Accountability Office report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt adva...
FDA publishes a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health eme...
FDA splits into two its guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators Dur...
FDA approves a Pfizer NDA for Zavzpret (zavegepant), the first calcitonin gene-related peptide receptor antagonist nasal spray for treating adults wit...
A letter from 18 Republican senators urges HHS to abandon a Medicare pricing model that aims to balance incentives for developing novel treatments und...
Baxter International issues an urgent medical device correction for its Life2000 Ventilation System due to the potential for patient oxygen desaturati...
FDA approves a Coherus BioSciences BLA for single-dose, prefilled autoinjector presentation of its Udenyca (pegfilgrastim-cbqv), a biosimilar of Amge...
