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Food and Drug Administration (FDA)
NEWS
JOBS
IN THE PRESS
NEWS
Policy
First Time Ever: FDA Asks Endo Pharma to Stop Selling Opana ER Amid Opioid Crisis
June 9, 2017
·
3 min read
Policy
Mark Your Calendars: Novartis AG’s CAR-T Drug Gets A Date With The FDA Next Month
June 7, 2017
·
1 min read
FDA
Forbes Under 30 Alumni Scores FDA Clearance For New Heart Monitor
June 7, 2017
·
1 min read
BioCapital
‘FDA Approved’ Medical Devices Don’t Actually Have To Do What They Promise
June 6, 2017
·
1 min read
Drug Development
Loxo Oncology Seeks FDA Approval After Breakthrough Drug Larotrectinib Helped Almost Everyone Who Took It
June 5, 2017
·
3 min read
Policy
Amgen Slaps Lawsuit On The FDA for Denying Six Months Of Pediatric Exclusivity For Sensipar
June 1, 2017
·
1 min read
Policy
Journalist Sues FDA for Documents Related to Sarepta’s DMD Drug
May 26, 2017
·
4 min read
Job Trends
New FDA Head Lifts Hiring Freeze, Takes Aim at the Next Martin Shkreli and Marathon Pharma
May 26, 2017
·
3 min read
Policy
There’s A Therapeutic Curveball Heading For The FDA
May 25, 2017
·
1 min read
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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
