SUBSCRIBE
SUBSCRIBE

Food and Drug Administration (FDA)

NEWS
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Vertex Gets FDA Approval for $259K Per Year CF Drug
July 6, 2015
 · 
3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Business
Vertex Poised to Become Profitable Following Expected FDA Approval of Orkambi
June 30, 2015
 · 
5 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Policy
Two Yale University Health Info Groups Sue FDA, Gilead for Hep C Drug Trial Data
June 30, 2015
 · 
5 min read
BioCapital
BioSpace Temperature Poll: After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff?
June 29, 2015
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
BioCapital
EXCLUSIVE: Cancer Therapy Benefits Realized Long After FDA Approval, Study Author Tells BioSpace
June 26, 2015
 · 
4 min read
BioCapital
Will The FDA Trans Fat Ban Really Improve America’s Health?
June 17, 2015
 · 
1 min read
BioCapital
FDA: Drug Companies Routinely Hide The Reasons Their Drugs Are Rejected From Investors
June 15, 2015
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AVEO Oncology Tumbles on Disappointing FDA Feedback for Tivozanib
June 12, 2015
 · 
5 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs Amgen’s Repatha, But With Strings Attached
June 11, 2015
 · 
4 min read
Load More
JOBS
IN THE PRESS
Press Releases
PharmaEssentia Announces FDA Approval and U.S. Launch of BESREMi Pen™ (ropeginterferon alfa-2b-njft) for Polycythemia Vera
June 26, 2026
 · 
5 min read
Press Releases
Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma
June 26, 2026
 · 
4 min read
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
Load More