SUBSCRIBE
SUBSCRIBE

Food and Drug Administration (FDA)

NEWS
FDA
First Remote-Control Leg Lengthening Implant Cleared by the FDA, Sinai Hospital Reveals
February 8, 2012
 · 
1 min read
BioCapital
Device Makers Said to Double FDA Fees to Produce Faster Reviews
February 1, 2012
 · 
1 min read
BioCapital
FDA Gets Sued for Snooping on Workers
January 30, 2012
 · 
1 min read
BioCapital
Is It A Drug? Is It a Device? No, It’s FDA’s Subjective “Chemical Action” Guidance
January 19, 2012
 · 
1 min read
Policy
FDA Misses Deadline in Clash With Device-Makers Over Reviews
January 18, 2012
 · 
1 min read
BioCapital
Coke Says It Found Fungicide in Orange Juice, FDA Has Been Alerted
January 13, 2012
 · 
1 min read
BioCapital
FDA Drafts Pharma Social Media Advice
January 4, 2012
 · 
1 min read
BioCapital
FDA Proposes Draft Guidelines Intended to Improve the Representation of Women in Medical Device Clinical Studies
December 16, 2011
 · 
3 min read
BioCapital
Should the FDA Be an Independent Agency?
December 14, 2011
 · 
1 min read
Load More
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
 · 
6 min read
Press Releases
Satellos Receives FDA Fast Track Designation for SAT-3247 for the Treatment of Duchenne Muscular Dystrophy
June 29, 2026
 · 
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
 · 
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
 · 
14 min read
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
Load More