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FDA Grants Accelerated Approval to Emrelis (telisotuzumab vedotin-tllv) for Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

 AbbVie (NYSE: ABBV) today announced that Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug...

FDA Approves Merck’s Welireg (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL)

(BUSINESS WIRE) May 14, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration...

All-Cause Mortality Higher With Sleep Deprivation in Seniors With Epilepsy

Older adults with sleep deprivation and epilepsy have an elevated risk for all-cause mortality, according to a study published online April 23 in Healthcare. Srikanta...

AAP Updates Guidelines for Pediatric Atopic Dermatitis Management

In a clinical report published online May 19 in Pediatrics, the American Academy of Pediatrics presents updated guidance for the treatment of children...

Use of Composite Allocation Score for Lung Transplant Wait List Improves Outcomes

Wait-list outcomes for lung transplants have substantially improved in the composite allocation score (CAS) era, according to a study presented at the...

MRI-Guided Biopsy Linked to Durability of Active Surveillance in Prostate Cancer

Use of magnetic resonance imaging (MRI)-guided biopsy (MRGB) could increase the durability of active surveillance (AS) in men with prostate cancer, according...

FDA Launches Postmarket Chemical Review Program to Ensure Food Safety

Last week, the U.S. Food and Drug Administration announced a move to improve transparency and strengthen the safety of chemicals used in the nation's food...

New Models Help Docs Distinguish Severe Pneumonia In Children

MONDAY, May 19, 2025 — New predictive models can accurately distinguish mild, moderate and severe pneumonia in children, helping determine which...

Former President Joe Biden Diagnosed With Aggressive Prostate Cancer

MONDAY, May 19, 2025 — Former President Joe Biden has been diagnosed with advanced prostate cancer that has spread to his bones, his office announced...

Doctors Perform First-Ever Human Bladder Transplant in U.S.

MONDAY, May 19, 2025 — Doctors in Southern California have performed the first human bladder transplant, offering new hope to people with serious...

Broken Heart Syndrome Remains A Killer, Especially For Men

THURSDAY, May 15, 2025 — “Broken heart syndrome” sounds like a romantic, fairy-tale notion — the idea that suffering a devastating...

FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia

Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the Division of Neurology 1 within FDA's Office of Neuroscience informed the...

The New England Journal of Medicine Publishes Data from Phase 2b Trial of Oral Orexin Receptor 2 Agonist Oveporexton (TAK-861) in People with Narcolepsy Type 1

OSAKA, Japan and CAMBRIDGE, Massachusetts, May 14, 2025 – Takeda (TSE: 4502/NYSE:TAK) today announced that the New England Journal of Medicine published...

In New SELECT Trial Analysis, Early Reduction in Cardiovascular Events Was Observed with Wegovy®, Before Clinically Meaningful Changes in Body Weight

Today, Novo Nordisk will present data at the European Congress of Obesity (ECO) from a secondary, post hoc analysis of the SELECT trial that showed...

FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market

The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products...

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Latest FDA New Drug Approvals

  • Emrelis Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous...
  • Avmapki Fakzynja Co-Pack Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated...
  • Imaavy Imaavy (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) blocker used for the treatment of generalized myasthenia gravis.

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Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...

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