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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...

Almost One-Quarter of U.S. Firearm Suicides May Occur Outside the Home

A growing number of firearm suicides in the United States occur outside the home, most commonly in motor vehicles, according to a study published online...

FDA Approves Polypill Widaplik for Hypertension

The U.S. Food and Drug Administration has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.The combination...

Mailed Self-Collection Kits Increase Rates of Cervical Cancer Screening

Mailed self-collection (SC) kits may increase participation in cervical cancer screening, according to a study published online June 6 in JAMA Internal...

Attrition Rates High Among Lesbian, Gay, Bisexual Medical Students

Medical school attrition rates are high among lesbian, gay, or bisexual (LGB) medical students, according to a research letter published online June 10...

988 Contacted More Than 16 Million Times From Its Launch to December 2024

Opportunities remain to increase use of the 988 Suicide and Crisis Lifeline, according to a research letter published online June 9 in JAMA Network Open. Jonathan...

FDA Plans to Use AI to Speed Up Drug and Food Safety Reviews

WEDNESDAY, June 11, 2025 — The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval...

Midea Recalls 1.7 Million AC Units Over Mold Risk

WEDNESDAY, June 11, 2025 — More than 1.7 million window air conditioners are being recalled because of a risk for mold growth, which can lead to...

These Smiling Salamanders Are Helping Scientists Learn to Regrow Limbs

WEDNESDAY, June 11, 2025 — With their goofy grins and feathery gills, axolotls have become stars of the pet world and video games like Minecraft.  But...

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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Recently added consumer and prescribing information: Ibtrozi, Miudella, Opdivo Qvantig, Alyftrek, Crenessity, Ensacove, Steqeyma, Yesintek, Revuforj, Danziten

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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...

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