FDA clears a Huxley Medical 510(k) for at-home sleep apnea diagnostic patch, Sansa.
FDA publishes a draft guidance on developing drug and biological treatments for a specific bladder cancer.
FDA approves a Citius Pharmaceuticals BLA for Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-cell lymphoma.
FDA approves a Purdue Pharma NDA for Zurnai, a nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose...
Federal Register notice: FDA announces a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA for its urinary trac...
Federal Register notice: FDA reopens the comment period for its proposed administrative order entitled Amending Over-the-Counter Monograph M013: Inter...
The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers on several issues relating to prescription drug pro...
FDA approves a Servier Pharmaceuticals NDA for Voranigo (vorasidenib) for treating certain adult and pediatric patients 12 years and older with Grade ...
