FDA News

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb Transforms the Classical Hodgkin Lymphoma Treatment Paradigm with Expanded U.S. and EMA Approvals for Opdivo® (nivolumab)...

ORLANDO, Fla.--(BUSINESS WIRE)--Imaginostics, Inc. today announced that it has received a Letter of Support from Siemens Healthineers in connection with ongoing exploratory discussions regarding potential collaboration in quantitative MRI and imaging biomarkers. As part of these discussions, Imaginostics and Siemens Healthineers intend to continue dialogue concerning potential technical and commercial pathways for Imaginostics’ envisioned ImagiView™ and ImagiSight™ offerings and their potential...

AUSTIN, Texas--(BUSINESS WIRE)--IntraBio Inc. today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for levacetylleucine for the treatment of Ataxia-Telangiectasia (A-T), a rare, progressive, inherited neurodegenerative disorder. This submission represents the first regulatory application submitted to the U.S. Food and Drug Administration seeking approval of a therapy for the treatment of Ataxia-Telangiectasia. The sNDA seeks...

PALO ALTO, Calif.--(BUSINESS WIRE)--Siemens Healthineers announced that its Varian TrueBeam radiotherapy systems, which include TrueBeam, TrueBeam STx, VitalBeam, and Edge, have received FDA 510(k) clearance for the use of low-dose radiation therapy (LDRT) in adults with medically refractory osteoarthritis (OA). This clearance expands Varian’s radiotherapy systems beyond cancer care into chronic musculoskeletal conditions, bringing precision radiotherapy to millions of people living with persis...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided an update on its ongoing regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding AMONDYS 45® (casimersen) and VYONDYS 53® (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD). Sarepta requested a meeting with FDA to discuss submitting supplemental new drug applications (sNDA) seeking conversion of the ac...

LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with an apnea-hypopnea index (AHI) between 15 and 65...

WOODBURY, N.Y.--(BUSINESS WIRE)--BioIVT, the leading biospecimen solutions provider and global research partner for drug and diagnostic development, today announced its presence at the 65th Annual SOT Meeting and ToxExpo, taking place March 22–25, 2026, in San Diego, where the company will present new scientific contributions. In addition, BioIVT will host an in-person symposium, “Elevating Drug Development with NAMs: Meeting the FDA’s Call for Change,” in Boston followed by a virtual discussio...

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the successful completion of 13 ventricular ablation procedures at leading institutions using the Company’s proprietary Ultra-Low Temperature Ablation (ULTA) technology under Expanded Access authorization from the U.S. Food and Drug Administration (FDA). The procedures addr...

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, highlighted the first use of its eMTBR-tau243 plasma assay in a Phase 3 dataset (Evoke/Evoke+), reflecting ongoing interest in tau-related signals within Alzheimer’s disease research. The data were presented at the AD/PD™ 2026 Alzheimer's & Parkinson's Diseases Conference during the Evoke/Evoke+ Trial Symposium, which focused on Evoke and Evoke+ cereb...

BOSTON & STAFFORDSHIRE, England--(BUSINESS WIRE)--Instem announces a 5-year extension of its Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA)....