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Food and Drug Administration (FDA)

NEWS
Wall Street's Top Biotech Analyst Loves These 2 Life Science Stocks
Drug Development
3 Biotechs With Make-or-Break Trial Results, FDA Meetings Coming Soon
September 22, 2017
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3 min read
Policy
How FDA Commissioner Gottlieb Plans To Seal An Orphan Drug Loophole
September 13, 2017
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1 min read
It's Official: New FDA Head Confirmed
Policy
FDA’s Gottlieb Has Big Plans to Get Drugs Approved Faster, Tackle Drug Development Costs
September 12, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Policy
FDA Berates Pfizer Unit for EpiPen Misfires During ‘Life-Threatening Emergencies’
September 8, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
FDA Calls Regeneron, Sanofi Carcinoma Drug a Breakthrough
September 8, 2017
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2 min read
Celgene Cuddles Up With Another Cambridge Biotech, This Time to Tackle Autoimmune Diseases
Drug Development
FDA Orders 6 Partial or Full Clinical Holds on Celgene’s Blood Cancer Studies
September 7, 2017
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2 min read
Bristol-Myers Squibb's Stock Topples as Kidney Cancer Drug Flunks Phase III Study
Drug Development
FDA Slaps Partial Hold on 3 of Bristol-Myers Squibb’s Opdivo-Based Combo Trials
September 7, 2017
 · 
3 min read
BioMidwest
FDA Warns Entellus Medical Over Serious Violations for Its Xpress Sinus Dilator Pediatric Trial
September 6, 2017
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1 min read
Policy
How To Work With The New FDA
September 5, 2017
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1 min read
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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
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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
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10 min read
Press Releases
FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance
June 25, 2026
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17 min read
Press Releases
ADC Therapeutics Announces Strategic Reorganization to Support ZYNLONTA® Growth Opportunities and Regulatory Priorities
June 24, 2026
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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
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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
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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
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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
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4 min read
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