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FDA

FDA
Panel Approves The Pill/Folic Acid Combo
October 19, 2005
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1 min read
FDA
Cancer Gene Therapy Is First To Be Approved
October 19, 2005
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1 min read
FDA
WHO Approves Use Of New Combination AIDS Pills
October 19, 2005
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1 min read
FDA
Controversial Primate Experiment Lab Approved
October 19, 2005
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1 min read
FDA
Cannabis Drug On Sale In Canada
October 19, 2005
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1 min read
FDA
Anthrax Test, Developed By Army And CDC, Receives FDA Approval
October 19, 2005
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1 min read
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PRESS RELEASES
Press Releases
Xenocor Announces FDA Clearance of Saberscope®, the First Single-Use 5mm Articulating Laparoscope for Enhanced Surgical Visualization
February 24, 2026
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3 min read
Press Releases
Olympus Announces Pediatric Use Indication for Two Single-Use Bronchoscopes
February 24, 2026
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3 min read
Press Releases
Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma
February 24, 2026
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3 min read
Press Releases
Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis
February 24, 2026
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19 min read
Press Releases
Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS)
February 24, 2026
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28 min read
Press Releases
Alpha Tau Medical Receives Japanese Marketing Approval for Alpha DaRT® in Unresectable Locally Advanced or Locally Recurrent Head and Neck Cancer
February 24, 2026
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7 min read
Press Releases
ORYZON Receives European Medicines Agency Approval to Initiate a Phase II Study of iadademstat in Essential Thrombocythemia
February 24, 2026
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10 min read
Press Releases
Aktis Oncology Receives U.S. FDA Fast Track Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate
February 24, 2026
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6 min read
Press Releases
Nexalin Announces Pivotal HALO™ Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market
February 24, 2026
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7 min read
Press Releases
Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026
February 24, 2026
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10 min read
Press Releases
Amphastar Announces FDA Approval for Ipratropium Bromide HFA
February 24, 2026
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5 min read
Press Releases
MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial
February 24, 2026
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5 min read
Press Releases
Haemonetics Receives FDA Clearance for NexSys® PCS Plasma Collection System with Persona® PLUS Technology
February 24, 2026
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3 min read
Press Releases
MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System
February 23, 2026
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3 min read
Press Releases
Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick Disease Type C
February 23, 2026
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5 min read
Press Releases
Ultragenyx Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application (BLA) for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)
February 23, 2026
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7 min read
Press Releases
Adial Pharmaceuticals Highlights FDA Policy Direction That May Reduce Pivotal Trial Burden from Two Studies to One
February 23, 2026
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6 min read
Press Releases
Daré Bioscience Announces FDA Clearance of IND for Phase 2 Clinical Study of DARE-HPV, a Potential Treatment for Persistent High-Risk HPV Infection, the Most Common Cause of Cervical Cancer
February 23, 2026
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11 min read
Press Releases
Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer
February 23, 2026
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4 min read
Press Releases
U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status
February 23, 2026
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3 min read
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