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U.S. FDA Approves Expanded Indication for AbbVie's Mavyret (Glecaprevir/Pibrentasvir) as First and Only Treatment for People with Acute Hepatitis C Virus
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for Mavyret (glecaprevir/pibrentasvir),...
FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1-Positive Non-Small Cell Lung Cancer
(BUSINESS WIRE) June 11, 2025 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer...
U.S. FDA Approves Tablet Formulation of BeOne’s Brukinsa for All Approved Indications
(BUSINESS WIRE) Jun 11, 2025 -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S....
FDA Approves Xifyrm (meloxicam) Injection for the Management of Moderate-to-Severe Pain in Adults
Woburn, MA — June 10, 2025 — Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Xifyrm...
FDA Approves Enflonsia (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants
(BUSINESS WIRE) June 9, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration...
FDA Approves Widaplik (telmisartan, amlodipine and indapamide) for the Treatment of Hypertension
London, UK, Boston, MA, 9 June 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic...
Generative AI Model for Draft Radiological Reporting Improves Documentation Efficiency
Clinical use of artificial intelligence (AI)-generated draft radiograph reports is associated with improved radiologist documentation efficiency while...
Shorter Leukocyte Telomere Length Linked to Higher Incidence of Age-Related Brain Diseases
Individuals with shorter leukocyte telomere length (LTL) have a higher incidence of stroke, dementia, and late-life depression (LLD), individually and...
Real-World Weight Loss With Semaglutide, Tirzepatide Less Than That Seen in Clinical Trials
For patients with obesity initiating pharmacotherapy with semaglutide or tirzepatide, weight loss at one year is 8.7 percent on average, which is lower...
RFK Jr. Installs Critics on Vaccine Recommendation Panel
THURSDAY, June 12, 2025 — Days after ousting all 17 members of the panel that makes U.S. vaccine recommendations, Health Secretary Robert F. Kennedy...
Mitochondrial Genetics Key to Metastatic Melanoma Immunotherapy Resistance
For patients with metastatic melanoma, mitochondrial (MT) haplogroup T (HG-T) is associated with resistance to an anti-programmed cell death protein-1-based...
RFK Jr. Hires Autism Skeptic To Look Into CDC Autism Data
THURSDAY, June 12, 2025 — A longtime vaccine critic hired by Health Secretary Robert F. Kennedy Jr. is reviewing safety data in an effort to revisit...
New Antibody Shot, Enflonsia, Could Help Protect Babies From RSV
THURSDAY, June 12, 2025 — A newly approved shot could soon help protect babies from respiratory syncytial virus (RSV), the top cause of hospitalization...
Zicam and Orajel Swabs Recalled for Possible Fungal Contamination
THURSDAY, June 12, 2025 — Some nasal and baby teething swabs from Zicam and Orajel are being recalled across the country because they may be contaminated...
Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders,...
Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia
(BUSINESS WIRE) June 9, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from...
Church & Dwight Issues Voluntary Nationwide Recall of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs Due to Microbial Contamination
Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and...
There's A Better Clot-Preventing Option Than Aspirin, Researchers Say
FRIDAY, June 6, 2025 — There’s a better option than daily aspirin to protect heart patients with a stent against dangerous blood clots, a new...
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Latest FDA New Drug Approvals
- Ibtrozi Ibtrozi (taletrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic...
- Xifyrm Xifyrm (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) for use in the management of moderate-to-severe pain.
- Enflonsia Enflonsia (clesrovimab-cfor) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for passive immunization...