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BioPorto initiates U.S. Adult Validation Study following U.S. Food and Drug Administration (FDA) feedback
June 9, 2026
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5 min read
Press Releases
U.S. Food and Drug Administration Accepts BioMarin’s Supplemental New Drug Application for Full Approval of VOXZOGO® (vosoritide) for Children With Achondroplasia
July 13, 2026
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Medicus Pharma Announces U.S. Food and Drug Administration (FDA) Submission of Rare Pediatric Disease Designation Request for SkinJect® in Gorlin Syndrome
June 15, 2026
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U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma
July 13, 2026
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Selective PPARα Modulator “K-808" (Pemafibrate) Granted “Breakthrough Therapy” Designation by the U.S. Food and Drug Administration (FDA) As a Treatment for Primary Biliary Cholangitis
June 30, 2026
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2 min read
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Vivos Inc. (OTCQB: RDGL) submits Early Feasibility Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel® Precision Radionuclide Therapy™
June 7, 2026
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Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device
June 30, 2026
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1 min read
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Pierre Fabre Pharmaceuticals Announces Regulatory Update Following Type A Meeting with U.S. Food and Drug Administration (FDA) on Tabelecleucel Biologic License Application (BLA)
May 7, 2026
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3 min read
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Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1
June 14, 2026
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6 min read
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Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19
June 10, 2026
·
15 min read
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