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FDA Approval

Every phase of the Food and Drug Administration's approval process, from filing to eventual approval, is covered in this section, including appeals, resubmissions, and safety warnings. New products, drugs, therapies, and treatments are covered here.
Latest FDA Approval
Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®
FDA Approval
/ March 17, 2025, 19:13 UTC
FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
FDA Approval
/ March 6, 2025, 22:12 UTC
FIRST AND ONLY TREATMENT FOR CHRONIC HYPOPARATHYROIDISM APPROVED IN AUSTRALIA
FDA Approval
/ March 6, 2025, 16:56 UTC
NAVER D2SF-Backed PranaQ® Receives FDA 510(k) Clearance for TipTraQ, an AI-Enabled Home Sleep Apnea Test
FDA Approval
/ March 5, 2025, 14:42 UTC
Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA
FDA Approval
/ March 4, 2025, 12:42 UTC
Navi Medical Technologies’ Neonav® ECG Tip Location System Receives FDA 510(k) Clearance
FDA Approval
/ February 28, 2025, 16:45 UTC
FDA Grants Orphan Drug Designation to MicuRx’s MRX-5 for NTM Infections
FDA Approval
/ January 14, 2025, 17:28 UTC
Pilatus Biosciences Inc. Secures FDA Orphan Drug Designation for PLT012: A Breakthrough in Liver and Intrahepatic Bile Duct Cancer Treatment
FDA Approval
/ December 20, 2024, 14:29 UTC
Accropeutics Inc. Announces U.S. FDA Clearance of IND Application for RIPK2 Inhibitor AC-101
FDA Approval
/ December 20, 2024, 14:29 UTC
RiboX Therapeutics Announces FDA Clearance for IND Application of RXRG001, the First Circular RNA Therapy for the Treatment of Radiation-Induced Xerostomia and Hyposalivation
FDA Approval
/ November 13, 2024, 22:12 UTC
Abionic’s CAPSULE PSP Receives FDA Approval for Early Detection of Sepsis; Fapon Introduces Exclusive PSP Solution in China via Licensing Collaboration
FDA Approval
/ November 13, 2024, 22:12 UTC
ZYMFENTRA® (infliximab-dyyb) coverage continues to increase through partnership with top 3 Pharmacy Benefit Managers (PBMs)
FDA Approval
/ November 13, 2024, 22:12 UTC
Formosa Pharmaceuticals and DÁVI Farmacêutica Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Post-Operative Inflammation and Pain
FDA Approval
/ November 13, 2024, 22:12 UTC
Medtronic announces FDA approval of Simplera™ CGM and global partnership with Abbott
FDA Approval
/ August 7, 2024, 21:12 UTC
Medtronic receives FDA approval for Inceptiv™ closed-loop spinal cord stimulator
FDA Approval
/ April 26, 2024, 21:12 UTC
Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis
FDA Approval
/ March 27, 2024, 21:12 UTC
GC collaborates with I.P. ONE to launch the “Vixol: Transformative Innovation for Sustainable World” campaign, marking the first time in Thailand of recycled colored plastic bottles.
FDA Approval
/ December 21, 2023, 12:12 UTC
FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform
FDA Approval
/ August 1, 2023, 02:12 UTC

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We're committed to your privacy. MedicaEx uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.