SUBSCRIBE
SUBSCRIBE

Food and Drug Administration (FDA)

NEWS
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
The FDA Calls Kyowa Hakko’s Lymphoma Drug a Breakthrough
August 25, 2017
 · 
2 min read
Sarepta Jumps Despite DMD Safety Issues in FDA Database
Policy
Sarepta’s Exondys 51 Saga Continues as More Details About FDA’s Criticism Uncovered
August 22, 2017
 · 
3 min read
Pharm Country
FDA Confirms Becton, Dickinson and Company Blood Tubes Not Linked to Inaccurate Lead Results
August 18, 2017
 · 
1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Heads Up Tesaro: AstraZeneca PLC, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA
August 18, 2017
 · 
3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
FDA Green Lights Pfizer Drug for Rare, Fast-Killing Type of Leukemia
August 18, 2017
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
This is What Happens When the FDA Approves Cancer Drugs Too Quickly
August 17, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Job Trends
FDA Puts in Place New Hiring Protocols for Foreign Scientists
August 14, 2017
 · 
3 min read
Biotech Bay
Mylan Badly Needs Help From FDA To Escape Its Woes And Deliver These Key Drugs
August 14, 2017
 · 
1 min read
Gilead Suffers Another R&D Setback as Myelofibrosis Drug Flops in Phase III, Gives Credence to Acquisition Urgency
Policy
Gilead’s HIV Triple Combo Gets Sped-up FDA Review, Decision Date Locked Down
August 11, 2017
 · 
3 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