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Food and Drug Administration (FDA)

NEWS
BioMidwest
Faulty St. Jude Medical Devices Were Used in Patients After Recall, Says FDA
April 17, 2017
 · 
1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Just Rejected Eli Lilly, Incyte’s Rheumatoid Arthritis Drug Baricitinib
April 14, 2017
 · 
2 min read
Policy
Mylan’s Shares Drop After FDA Lashes Out at Drugmaker for Drug Quality Control at HIV Drug Facility
April 12, 2017
 · 
1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Nothing’s Gonna Stop Neurocrine Now: Shares Jumped on FDA Approval of the First and Only Drug to Treat Tardive Dyskinesia for Adults
April 12, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Genetown
FDA Picks Boston’s Emulate for its Organ-on-a-Chip Technology
April 11, 2017
 · 
2 min read
FDA
Gilead Release: FDA Approves New Indications For Harvoni And Sovaldi In Pediatric Patients 12 Years And Older With Chronic Hepatitis C Infection
April 7, 2017
 · 
10 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases
April 6, 2017
 · 
2 min read
Regeneron's Top Execs Get a Huge Pay Cut in 2016, But It's Still More Than Most of Us Have Ever Dreamed of
Drug Development
FDA Calls Regeneron’s Evinacumab a Breakthrough
April 6, 2017
 · 
2 min read
Business
5 Things We Learned About FDA Nominee Scott Gottlieb
April 6, 2017
 · 
1 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
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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
 · 
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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