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Vitruvias Therapeutics, Inc. Issues Nationwide Recall of One Lot of Thyroid Tablets, USP 30 mg Due to Potential Super Potency
AUBURN, Ala.--(BUSINESS WIRE)--Vitruvias Therapeutics, Inc. is issuing a nationwide recall for a single lot of 30 mg Thyroid Tablets....
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FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review
STAMFORD, CT--(BUSINESS WIRE)--Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI’s U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review. Today’s action further enhances PMI’s leadership role in the smoke-free category. “We are del...
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Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced it has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) for the treatment of spinal muscular atrophy (SMA) in...
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FDA Clears C2N Diagnostics’ PrecivityAD2® — First Alzheimer’s Blood Test for Adults with Cognitive Symptoms as Young as 40
ST. LOUIS--(BUSINESS WIRE)--The U.S. Food & Drug Administration (FDA) has cleared C2N Diagnostics’ PrecivityAD2® test, providing patients and health care professionals with an accurate, accessible, and scalable blood test to help diagnose Alzheimer’s disease in conjunction with standard clinical workup. An estimated 19-20 million U.S. adults aged 65 and older, and hundreds of thousands more between ages 45 and 65 are living with cognitive impairment and may benefit from an early diagnosis1....
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Hyperfine Announces FDA Clearance of the Next Optive AI™ Software, Further Enhancing Image Quality, Clinical Utility, and Ease of Use of the Swoop® System Across Care Settings
GUILFORD, Conn.--(BUSINESS WIRE)--FDA-cleared Optive AI software enhances Swoop system image quality, clinical utility, ease of use, and isotropic imaging capability....
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Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer
PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--REZILIENT3 trial results have been selected for presentation in the Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer....
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Limbic Becomes First AI-Led Mental Healthcare Company Selected for FDA TEMPO
NEW YORK & LONDON--(BUSINESS WIRE)--Limbic is the first AI-led mental healthcare company selected by the U.S. Food and Drug Administration for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot. Through the pilot, Limbic will introduce Unpacked, a clinician-supervised AI-led mental health service for eligible Medicare beneficiaries with clinically significant depression or anxiety. The service will deliver cognitive behavioral therapy (CBT) through scheduled telephone conversation...
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Stoke Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)
BEDFORD, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced that, effective on August 17, 2026, it granted stock options to purchase an aggregate of 70,950 shares of common stock to seven...
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Genetix Biotherapeutics and the National Football League Alumni Association Announce Partnership to Increase Awareness for Sickle Cell Disease and Transformative Treatment Options
SOMERVILLE, Mass.--(BUSINESS WIRE)--Genetix Biotherapeutics Inc. and the National Football League Alumni Association today announced a partnership to launch a national awareness and education initiative for sickle cell disease. Through community engagement, the partnership will raise greater awareness of the difficulties of living with sickle cell disease, while helping individuals, families, and healthcare providers better understand available treatment options and support services. Many famil...
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Cytovance Biologics Launches Standalone Analytical Services to Accelerate Biologics Development
OKLAHOMA CITY--(BUSINESS WIRE)--Cytovance Biologics, a leading US-based contract development and manufacturing organization (CDMO) serving the biopharmaceutical industry, today announced the expansion of its analytical services portfolio with standalone analytical capabilities for biotechnology and pharmaceutical clients. The new approach provides access to Cytovance's experienced analytical team and regulatory-ready analytical solutions without requiring a manufacturing engagement. Building on...