fda

Transmural Systems Receives FDA 510(k) Clearance for TELLTALE

ANDOVER, Mass.--(BUSINESS WIRE)--Transmural Systems, a leader in pioneering electrosurgical structural heart therapies, obtained 510(k) clearance from the United States Food…

4 days ago

In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula

NEW YORK--(BUSINESS WIRE)--ByHeart, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen…

2 weeks ago

LENZ Therapeutics Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights

November 05, 2025 08:00 ET  | Source: LENZ Therapeutics, Inc. VIZZTM (aceclidine ophthalmic solution) 1.44% received FDA approval for the…

3 weeks ago

Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes

LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering therapies that target the root causes…

1 month ago

Domp’s Program in NAION Selected for Landmark FDA Commissioners National Priority Voucher Program

One of just nine voucher recipients chosen and the only one in the eye space, the selection spotlights Dompé’s dedication…

1 month ago

Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner’s National Priority Voucher Pilot Program

REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing…

1 month ago

Berlin Heals Holding AG Successfully Completes Enrollment in Phase I of the CMIC-III Less Invasive Study

Completed Enrollment in First-In-Human Phase I study of Less Invasive Approach Expected to Present 6-Month data in 2026 at a…

2 months ago

Glac Biotech Secures U.S. Food and Drug Administration GRAS Approval for Probiotic Strain CP-9

TAIPEI, Sept. 15, 2025 /PRNewswire/ -- Glac Biotech, a Taiwan-based developer of probiotics and postbiotics, announced that its core probiotic…

2 months ago

U.S. FDA Approves Expanded Indication for VONVENDI [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease

− Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with…

3 months ago

Novo Nordisk A/S: Wegovy approved in the US for the treatment of MASH

Bagsværd, Denmark, 15 August 2025 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved an…

3 months ago