Tag: fda

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…

Business Wire

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

November 05, 2025 08:00 ET  | Source: LENZ Therapeutics, Inc. VIZZTM (aceclidine…

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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…

PRNW Agency

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…

Business Wire

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.…

GlobeNews Wire

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…

PRNW Agency

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…

PRNW Agency

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…

GlobeNews Wire

Regen BioPharma Discusses Potential Impact of HemaXellerate on Chemotherapy Treament Market

SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC…

GlobeNews Wire