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Food and Drug Administration (FDA)
NEWS
JOBS
IN THE PRESS
NEWS
Drug Development
Thiel-Backed Biotech Rational Vaccines Will Follow FDA Guidelines After Offshore Trial Controversy
September 5, 2017
·
1 min read
FDA
Novartis AG Waltzes to the Finish Line With First Ever FDA Approval for CAR-T
August 30, 2017
·
3 min read
BioCapital
Will The FDA Succeed In Reining In Risk Info In Drug Ads?
August 30, 2017
·
1 min read
Policy
FDA Clarifies Early Feasibility Study Program For Innovative Medical Devices
August 30, 2017
·
1 min read
Policy
FDA Cracks Down On Clinics Selling Unproven Stem Cell ‘Therapies’
August 29, 2017
·
1 min read
Policy
Acorda Plunges After the FDA Rejects Marketing App for Parkinson’s Disease Drug
August 29, 2017
·
3 min read
Lone Star Bio
Revisiting Neos Therapeutics Before Key FDA Date
August 28, 2017
·
1 min read
Policy
What The FDA’s New Pre-Certification Program Means For Digital Health And Medical Device Industries
August 28, 2017
·
1 min read
FDA
Adamas Wins FDA OK for the First and Only Drug for Parkinson’s Dyskinesia Drug
August 25, 2017
·
3 min read
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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
