United States Food and Drug Administration
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Fabhalta, United States Food and Drug Administration, Apellis, Novartis, Approved, C3 G, Proteinuria, pegcetacoplan, Kidney Diseases
J&J advances Stelara succession scheme with FDA nod for Tremfya in Crohn’s disease
Tremfya, United States Food and Drug Administration, Crohn ‘s disease, Approved, CD, J&J ‘s
Alnylam’s Amvuttra Approved for ATTR Cardiomyopathy, Challenging Pfizer and BridgeBio
Amvuttra, vutrisiran, ATTR-CM, FDA approval, RNAi therapeutic, cardiomyopathy
Trump blog: FDA, NIH picks clear Senate panel; FDA top lawyer resigns
United States Food and Drug Administration, NIH Mouse, Senate
Merck’s HIV Combo Treatment Advances Towards FDA Filing
Doravirine/islatravir (DOR/ISL) combination, Phase 3 trials, Viral suppression, Once-daily oral regimen, FDA submission
FDA’s medical review departments remain largely untouched (for now) by Musk-led cuts
FDA, medical review, drug approval, device regulation, staff cuts, Elon Musk, DOGE, government efficiency
On the heels of FDA nod for cancer drug, Sun Pharma buys Checkpoint Therapeutics for up to $416M
UNLOXCYT, Checkpoint Therapeutics, Squamous cell carcinoma of skin, United States Food and Drug Administration, Sun Pharma
Mineralys Phase 3 blood pressure pill data support potential FDA approval
United States Food and Drug Administration, Launch-HTN, Uncontrolled, Hypertensive disease, Approved
FDA Approves First Treatment for Macular Telangiectasia Type 2 (MacTel)
ENCELTO, revakinagene taroretcel-lwey, MacTel, FDA approval, encapsulated cell therapy, ciliary neurotrophic factor (CNTF)
In confirmation hearing, FDA nominee Martin Makary talks drug reviews, vaccines, ethics and more
United States Food and Drug Administration, Makary, Vaccines, Ethics, Advisory Committees