Drug Approvals

FDA Accepts VOXZOGO sNDA; PDUFA Feb. 28, 2027

FDA · Rare Diseases · 3 min

FDA Approves LEQEMBI IQLIK SC Initiation for Alzheimer

FDA · Alzheimer's Disease · 3 min

FDA Grants Fabhalta Traditional Nod, -48% eGFR Slope

FDA · Kidney Disease · 3 min

FDA Approves LYTENAVA Ophthalmic Bevacizumab for Wet AMD

FDA · Ophthalmology · 3 min

FDA Fast Tracks Lundbeck Lu AH69593 for Narcolepsy

FDA · Neurology · 3 min

Monopar Starts Rolling NDA for ALXN1840 Wilson

FDA · Rare Diseases · 3 min

Par Health Launches First Janumet XR Generic

FDA · Diabetes · 3 min

FDA Approves TYLENOL with Naproxen OTC Combo

FDA · Pain Management · 3 min

FDA Accepts BridgeBio Encaleret NDA for ADH1

FDA · Rare Diseases · 3 min

FDA Accepts Daraxonrasib NDA for Pancreatic Cancer

FDA · Oncology · 3 min

FDA Accepts Dyne BLA for z-Rostudirsen in DMD

FDA · Rare Diseases · 3 min

FDA Approves GSK Jideytro for ROS1+ NSCLC

FDA · Oncology · 3 min