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Food and Drug Administration (FDA)
NEWS
JOBS
IN THE PRESS
NEWS
Policy
Prior to FDA Vote, Advisory Committee Cites Study Bias Concerns Over Amgen Cancer Vaccine
April 27, 2015
·
3 min read
Drug Development
FDA, Genervon and ALS Blogger Battle Over Clinical Trial Interpretation
April 21, 2015
·
3 min read
FDA
Analysts Cheer As Amgen Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor
April 16, 2015
·
2 min read
BioCapital
KIND Bars Claim To Be Healthy, The FDA Disagrees
April 15, 2015
·
1 min read
BioCapital
Why The FDA Doesn’t Really Know What’s In Your Food
April 15, 2015
·
1 min read
FDA Panel Wants Heart Risk Warnings for AstraZeneca PLC, Takeda Diabetes Drugs
April 15, 2015
·
3 min read
Policy
The Medicines Company’s Kengreal Gets FDA Support After Previous Setbacks
April 13, 2015
·
2 min read
Policy
New FDA Program Will Expedite Approval Of “Breakthrough” Medical Devices for Sickest Patients
April 10, 2015
·
1 min read
Drug Development
AstraZeneca PLC’s Diabetes Drug Onglyza May Increase Risk of Heart Failure, FDA Panel Reports
April 10, 2015
·
2 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
