FDA releases the form FDA-483 issued following an inspection at the Nephron Pharmaceuticals warehouse in Murray, KY.
FDA approves AbbVies Rinvoq (upadacitinib) for treating adults with moderately to severely active Crohns disease.
FDA clears an Abbott 510(k) for its Assert-IQ insertable cardiac monitor for diagnosing and long-term monitoring of people experiencing arrhythmias.
Draeger Medical recalls its Seattle PAP Plus continuous positive airway pressure device and VentStar breathing components due to breathing circuit con...
Federal Register notice: FDA releases a draft guidance entitled Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharma...
Federal Register notice: FDA makes available a draft guidance on how to qualify for pediatric drug exclusivity.
Reps. Eshoo and McCaul reintroduce the Give Kids a Chance Act to authorize FDA to direct drug companies to perform pediatric cancer trials with combin...
Rep. Frank Pallone praises FDA steps to reduce the shortage of the cancer drugs carboplatin and cisplatin.
