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Food and Drug Administration (FDA)

NEWS
BioCapital
10 Popular Products Not Endorsed By FDA
March 25, 2015
 · 
1 min read
Policy
Faster FDA Means More Cancer Breakthroughs
March 24, 2015
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1 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs GlaxoSmithKline, Theravance’s Breo for Adults, Not Kids
March 20, 2015
 · 
2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Policy
Merck & Co. Can’t Catch a Break for Sugammadex, Faces Third FDA Rejection
March 16, 2015
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2 min read
Policy
FDA Now Requires Proof That Reusable Medical Devices Can Be Reliably Cleaned
March 13, 2015
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Pharm Country
FDA Warns of Seizure, Alcohol Risk With Pfizer’s Anti-Smoking Drug Chantix
March 10, 2015
 · 
2 min read
BioCapital
10 Advantages Of Getting Your Device Approved By FDA
March 6, 2015
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
Genetown
GI Dynamics Stock Freefalls After FDA Halts Trial
March 6, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Policy
Stock Jumps as FDA Staff Backs Kythera’s Double Chin Injection
March 6, 2015
 · 
2 min read
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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
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