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NEW YORK--(BUSINESS WIRE)--ByHeart, a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin. This action underscores ByHeart’s core mission: p...

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis was named BioTechnology Innovator of the Year in the 2025 BioTech Breakthrough Awards, honoring its innovation in digital validation....

NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a pioneer in metabolically healthy weight loss, today announced it has passed critical milestones in the U.S. Food and Drug Administration (the “FDA”) Pre-Market Approval (“PMA”) process for the Allurion Smart Capsule. In addition, the Company announced it has entered into a transaction with its creditor to exchange all of its outstanding debt and obligations under its Revenue Interest Financ...

SAN CARLOS, Calif.--(BUSINESS WIRE)--ZAP Surgical Systems, Inc., a pioneer in non-invasive robotic brain surgery, today announced that its award-winning ZAP-Axon® Radiosurgery Planning System has received both U.S. FDA 510(k) clearance and European CE certification. These key regulatory milestones authorize clinical use of ZAP-Axon throughout the United States and European Union, marking a significant advance in the evolution of world-class radiosurgery planning. Dedicated exclusively to crania...

BOSTON--(BUSINESS WIRE)--In recognition of Veterans Day, AcuityMD announces its partnership with Electromedical Products International (EPI) to drive access to Alpha-Stim®, a non-invasive, FDA-cleared device that uses cranial electrotherapy stimulation (CES) and microcurrent electrical therapy (MET) to treat anxiety, insomnia, and pain for U.S. military veterans. While available to all patients diagnosed with these conditions, Alpha-Stim is uniquely appealing to veterans who may have concerns w...

MADISON, Wis.--(BUSINESS WIRE)--The Promega OncoMate® MSI Dx Analysis System has received FDA approval as a companion diagnostic for KEYTRUDA® plus LENVIMA® in endometrial carcinoma....

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL) (“Precision”), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it has agreed to sell by way of an underwritten offering 10,815,000 shares of its common stock and accompanying warrants to purchase up to 5,407,500 shares of common stock at a combined price of $6.14 and, in lieu of common stock t...

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced a late-breaking oral presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025. The presentation includes data from the ongoing ELIMINATE-B Phase 1 study evaluating PBGENE-HBV, a first-in-class in vivo g...

TEL AVIV, Israel--(BUSINESS WIRE)--Remilk, a global leader in the development and production of real dairy products made without cows, and Gad Dairies, a household name and one of Israel’s leading dairy brands, announced today (Monday) the launch of “The New Milk” – a revolutionary creation that delivers the perfect combination of rich, authentic taste and exceptional nutritional value. The product is now being rolled out in cafés and restaurants across Israel and will reach major retail chains...

STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. (“Purdue”) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pipeline drug tinostamustine for the treatment of malignant gliomas, a broad category of brain and spinal cord cancers that affect both adults and children and includes rapidly growing, invasive tumors like glioblastoma. As many as 22,000 people are diagnosed with malignant gliomas annually in the United States1. FDA gr...