FDA issues an alert after becoming aware that Abbott issued a letter to customers recommending updated instructions when removing the TactiFlex Ablati...
FDA releases the form FDA-483 with six observations from an inspection at Wichita, KS-based Fagron Compounding Services.
FDA approves Biocon Biologics biosimilars for Amgens Prolia and Xgeva.
FDA issues a draft guidance revising and updating a 2013 guidance on safety labeling changes when new safety information becomes available after a dru...
The House Energy and Commerce Committee unanimously approves legislation to reauthorize FDAs Rare Pediatric Disease Priority Review Voucher program.
FDA approves an AstraZeneca supplemental NDA for Airsupra (albuterol/budesonide) to expand the drugs labeling to reflect a 46% reduction of severe exa...
FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux disease in adults.
Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis drug icotrokinra outpe...
