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Food and Drug Administration (FDA)

NEWS
BioCapital
FDA Labels Pelvic Mesh As “High-Risk” Medical Device
January 5, 2016
 · 
1 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Drug Development
Investors Await Four Key FDA Decisions in the First Quarter of 2016
January 4, 2016
 · 
2 min read
BioCapital
FDA Expected To Add Value To Wearable Medical Device Market
December 28, 2015
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Actelion’s Uptravi Received FDA Approval, to Enter U.S. Market in January
December 22, 2015
 · 
2 min read
BioCapital
FDA Overturns 30-Year Ban On Blood Donations By Gay Men
December 22, 2015
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1 min read
BioCapital
Medical Device Makers Get A Little Help From The FDA
December 21, 2015
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1 min read
FDA Grants Stimrelieve IDE Approval For A Wireless Craniofacial Nerve Stimulator (CFNS) For The Treatment Of Craniofacial Neuropathic Pain
December 2, 2015
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3 min read
Pharm Country
Four Key FDA Decisions Expected By Year End
November 30, 2015
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
Policy
BioMarin Stock Halted as FDA Bashes Muscle Wasting Drug
November 25, 2015
 · 
3 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
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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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