SUBSCRIBE
SUBSCRIBE

Food and Drug Administration (FDA)

NEWS
Gilead Suffers Another R&D Setback as Myelofibrosis Drug Flops in Phase III, Gives Credence to Acquisition Urgency
FDA
FDA Green Lights Gilead’s Vosevi, With a Black Box Warning Attached
July 19, 2017
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Puma Biotech Surges After the FDA Officially Approves Breast Cancer Drug
July 18, 2017
 · 
2 min read
It's Official: New FDA Head Confirmed
Job Trends
Gottlieb Lays Out Plans to Attract and Preserve Top Talent at the FDA
July 18, 2017
 · 
2 min read
Policy
FDA’s 60-Day Extension For Medical Device Defects Not Likely Obstructive To Public Health
July 17, 2017
 · 
1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Policy
Safety Issues Force the FDA to Turn Down Amgen, UCB SA’s Osteoporosis Drug
July 17, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Gives Nod to Johnson & Johnson’s Potential Blockbuster Psoriasis Med
July 14, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Panel Unanimously Endorses Novartis AG’s CAR-T Leukemia Drug
July 13, 2017
 · 
3 min read
BioCapital
One FDA About-Face Doesn’t Mean an Orphan-Drug Bonanza
July 12, 2017
 · 
1 min read
Policy
Novartis AG Avoided Deaths In CAR-T Trials But Long-Term Safety Is Key, Says The FDA
July 11, 2017
 · 
1 min read
Load More
JOBS
IN THE PRESS
Press Releases
FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy® (sacituzumab govitecan-hziy) as First-Line Treatment of PD-L1+ (CPS ≥10) Advanced Triple-Negative Breast Cancer (TNBC)
June 25, 2026
 · 
19 min read
Press Releases
U.S. FDA Approves Trodelvy® for First-Line Treatment of Metastatic Triple-Negative Breast Cancer
June 25, 2026
 · 
19 min read
Press Releases
TRYNGOLZA® (olezarsen) approved by the FDA as the first and only treatment to reduce triglycerides and the risk of acute pancreatitis in patients with severe hypertriglyceridemia (sHTG)
June 25, 2026
 · 
10 min read
Press Releases
FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance
June 25, 2026
 · 
17 min read
Press Releases
ADC Therapeutics Announces Strategic Reorganization to Support ZYNLONTA® Growth Opportunities and Regulatory Priorities
June 24, 2026
 · 
8 min read
Press Releases
Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes
June 24, 2026
 · 
8 min read
Press Releases
UniXell Biotechnology Secures FDA IND Clearance for UX-DA003, Achieving China-U.S. Dual Breakthrough in iPSC Parkinson’s Therapy
June 24, 2026
 · 
4 min read
Press Releases
Life Spine Receives FDA 510(k) Clearance for VersaLift™ Expandable Interbody System Featuring a 6mm Starting Height
June 24, 2026
 · 
1 min read
Press Releases
FDA Approves the HepQuant SHUNT® Liver Diagnostic Test to Quantify Risk of Large Esophageal Varices in Adult Patients with Compensated Cirrhosis (Child Pugh Class A)
June 24, 2026
 · 
5 min read
Press Releases
BioMendics Receives FDA Fast Track Designation for BM-3103 (TolaSure® Gel™) for Epidermolysis Bullosa Simplex
June 23, 2026
 · 
4 min read
Load More