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Food and Drug Administration (FDA)

NEWS
BioCapital
Henry Miller: FDA Has Device Makers Looking Outside U.S.
July 19, 2012
 · 
1 min read
BioCapital
U.S to Build Database of 100,000 Food Pathogen Genomes, FDA Reveals
July 13, 2012
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1 min read
Fat-Melting Device a Weighty Matter for FDA, RevecoMED Reveals
July 11, 2012
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1 min read
BioCapital
Metal Hip Implants: FDA Panel Sees Little Reason for Their Use
July 2, 2012
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1 min read
BioCapital
Medical Gear Packed Full of Dodgy Software: FDA
June 22, 2012
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1 min read
BioMidwest
Study Finds FDA Policies Hurt Medical Device Sales Jobs
June 20, 2012
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1 min read
More Proof FDA is Faster Than Other Drug Regulators
June 20, 2012
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1 min read
Biotech Beach
FDA Rule Clears Medical Devices Without Human Testing
May 21, 2012
 · 
1 min read
Policy
Acorda Therapeutics to FDA: What Deadlines?
May 17, 2012
 · 
1 min read
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JOBS
IN THE PRESS
Press Releases
Palisade Bio Receives FDA Clearance of IND for PALI-2108 and Plans to Initiate Global Phase 2 ASCENTRA-UC Study in Ulcerative Colitis
June 29, 2026
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6 min read
Press Releases
Satellos Receives FDA Fast Track Designation for SAT-3247 for the Treatment of Duchenne Muscular Dystrophy
June 29, 2026
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7 min read
Press Releases
Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD)
June 29, 2026
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14 min read
Press Releases
Larimar Therapeutics Reports Positive Open Label Data and Submission of First Module of Rolling BLA for Accelerated Approval of Nomlabofusp for Friedreich’s Ataxia
June 29, 2026
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14 min read
Press Releases
SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
June 28, 2026
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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
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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
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