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Food and Drug Administration (FDA)

NEWS
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Biotech Bay
Geron Corporation Soars As The FDA Removes Full Clinical Hold On Imetelstat
November 3, 2014
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2 min read
Deal-Starved Perrigo Company In Talks To Buy $5B Omega Pharma
FDA
FDA Panel Backs Daiichi Sankyo, Inc.'s New A-Fib Drug Savaysa
October 31, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
AstraZeneca PLC Wins FDA Approval For Two-In-One Diabetes Pill
October 30, 2014
 · 
2 min read
BioCapital
How Is The FDA Doing On Medical Device Review Times?
October 29, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Policy
Sarepta Therapeutics Tanks As FDA Seeks Further Data On Eteplirsen; Stock Down 32.47% At Market Close (Oct. 27, 2014)
October 27, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Policy
FDA Postpones Its Final Decision On NPS Pharmaceuticals, Inc.'s Natpara
October 24, 2014
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2 min read
Mylan Inc., Theravance, Inc. Partner Up for $265 Million COPD Pact
Hikma Pharmaceuticals Falls On FDA Warning For Portugal Plant
October 24, 2014
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1 min read
BioSpace’s Favorite FDA Tricks or Treats
Bio NC
BioSpace’s Favorite FDA Tricks Or Treats
October 24, 2014
 · 
8 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Vertex Pharmaceuticals (MA) Surges As FDA Advisory Panel Approves Kalydeco’s Label Expansion
October 22, 2014
 · 
2 min read
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JOBS
IN THE PRESS
Press Releases
SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
June 28, 2026
 · 
13 min read
Press Releases
Anivive Lifesciences Announces FDA Approval of Laverdia®, the First Oral Treatment of Its Kind for Canine Lymphoma
June 28, 2026
 · 
4 min read
Press Releases
Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy
June 28, 2026
 · 
6 min read
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
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