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FDA Approves Inluriyo (imlunestrant) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant, 200 mg tablets),...

FDA Approves Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection Formulation of Keytruda for Use in Solid Tumors

(BUSINESS WIRE) September 19, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug...

FDA Grants Accelerated Approval to Forzinity (elamipretide hydrochloride) for the Treatment of Barth Syndrome

NEEDHAM, Mass., Sept. 19, 2025 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a...

Mouse Study Offers Cautionary Tale About The Keto Diet

SUNDAY, Sept. 28, 2025 — It sounds counterintuitive: Eat more fat and lose more weight. But it’s the underpinning of a keto diet — a...

Wildfires in Western U.S. Play a Role in Global Warming, Research Shows

SATURDAY, Sept. 27, 2025 — Wildfires are an increasingly common feature of life in American West, and researchers are working overtime to understand...

Drop in Hospital Salaries, Staffing Reported After Private Equity Acquisitions

U.S. hospitals that undergo private equity acquisition may reduce salaries and staffing after acquisition, especially in emergency departments (EDs) and...

Poor Mental Health Outcomes More Likely With Hyperemesis Gravidarum

Hyperemesis gravidarum is associated with an increased risk for poorer mental health outcomes compared with pregnancy without hyperemesis gravidarum, according...

Mediterranean Diet Tied to Improvement in Psoriasis

A 16-week Mediterranean diet intervention significantly improves psoriasis severity in patients with mild-to-moderate disease receiving stable topical...

Alcohol Use Linked to Increased Dementia Risk

Alcohol use is associated with increased dementia risk, according to a study published online Sept. 23 in BMJ Evidence-Based Medicine. Anya Topiwala,...

New World Screwworm Parasite Detected in Northern Mexico Near U.S. Border

FRIDAY, Sept. 26, 2025 — A dangerous parasite once eliminated in the United States has been detected in northern Mexico, close to the U.S. border. Mexico’s...

Gene Therapy Slows Huntington’s Disease in Early Trial

FRIDAY, Sept. 26, 2025 — A new gene therapy has shown promise in slowing the progression of Huntington’s disease, according to early trial...

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer...

Women With Dense Breasts Benefit From Advanced Cancer Screening Procedures

WEDNESDAY, Sept. 24, 2025 — Women with dense breasts could benefit from an advanced cancer screening procedure called molecular breast imaging (MBI),...

FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility

(BUSINESS WIRE)--Sep. 23, 2025-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives...

Bayer Announces Progress for Bemdaneprocel and AB-1005 Potential Therapies Against Parkinson’s Disease

Berlin, September 22, 2025 – Bayer announced today progress for two potential therapies against Parkinson’s disease (PD). A first participant...

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Recently added consumer and prescribing information: Inluriyo, Forzinity, Enbumyst, Inlexzo, Nuvaxovid, mNEXSPIKE, Cyklx, Papzimeos, Brinsupri, Zegfrovy

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Latest FDA New Drug Approvals

  • Inluriyo Inluriyo (imlunestrant) is an estrogen receptor antagonist indicated for the treatment of adults with ER-positive, HER2-negative, ESR1-...
  • Keytruda Qlex Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) is a programmed death receptor-1 (PD-1)-blocking antibody and endoglycosidase...
  • Forzinity Forzinity (elamipretide hydrochloride) is a mitochondrial cardiolipin binder for the treatment of Barth syndrome.

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