FDA Approval Tracker

Track drug approvals, NDAs, BLAs, and regulatory milestones in real-time

OpenFDA + Drugs@FDA
47
Approved in 2026
23
Pending Review
12
Priority Reviews
8
Breakthrough
Recent Approvals
Wegovy (semaglutide) - Cardiovascular Indication
Novo Nordisk • Supplement Approval
Supplement

Expanded indication for reduction of cardiovascular events in adults with obesity and established cardiovascular disease.

Approved: Jan 28, 2026 Priority Review
Orforglipron (oral GLP-1)
Eli Lilly • New Molecular Entity
NDA

First oral non-peptide GLP-1 receptor agonist for type 2 diabetes and weight management.

Approved: Jan 22, 2026 Breakthrough Therapy
Epcoritamab-bysp (Epkinly) - DLBCL
AbbVie • Biologics License
BLA

Bispecific antibody for relapsed/refractory diffuse large B-cell lymphoma after two prior therapies.

Approved: Jan 18, 2026 Accelerated Approval
Generic Ozempic (semaglutide injection)
Teva Pharmaceuticals • Generic Application
ANDA

Generic version of semaglutide injection for type 2 diabetes management.

Approved: Jan 15, 2026 Standard Review
Upcoming PDUFA Dates
Donanemab (Alzheimer's)
Eli Lilly • Feb 15, 2026
Resmetirom (NASH)
Madrigal • Mar 1, 2026
Lecanemab SC (Alzheimer's)
Eisai/Biogen • Mar 20, 2026
KarXT (Schizophrenia)
Karuna/BMS • Apr 5, 2026
2026 Approvals by Type
NDA (New Drugs) 18
BLA (Biologics) 12
ANDA (Generics) 9
Supplements 8