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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...

FDA Grants Accelerated Approval to Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib tablets) for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

(BUSINESS WIRE)--May 8, 2025-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK...

Chimpanzees' Drumming May Be Ancient Form of Communication

SATURDAY, May 17, 2025 — When a chimp pounds rhythmically on a towering tree root deep in the jungle, it may be doing more than just making noise. A...

FDA Gives Marketing Nod to Blood Test for Diagnosing Alzheimer Disease

The first in vitro diagnostic device that uses blood samples to detect Alzheimer disease has been granted marketing clearance by the U.S. Food and Drug...

Greater Sedentary Time Associated With Higher Risk for Alzheimer Disease

Sedentary time is associated with an increased risk for Alzheimer disease (AD), according to a study published online May 13 in Alzheimer's & Dementia. Marissa...

Testosterone Use Not Tied to Gynecological Cancers in Transmasculine Individuals

Short-term testosterone use among transmasculine and gender diverse (TMGD) individuals is not associated with an increased risk for gynecological cancers,...

Risk for Death, MACE Increased for Patients With Adult-Onset Type 1 Diabetes

Adult-onset type 1 diabetes (T1D) is associated with an increased risk for death and major adverse cardiovascular events (MACE), according to a study published...

Audiologist-Fitted Hearing Aids Outperform Over-the-Counter Ones

Over-the-counter (OTC) hearing aids (HAs), in which audiologists provide limited services, are effective, but do not achieve the same outcomes as HAs fitted...

Novo Nordisk, U.S. Biotech Company Team Up to Create Obesity Pills

FRIDAY, May 16, 2025 — Danish drugmaker Novo Nordisk is teaming up with California-based biotech Septerna to develop new pills to treat obesity,...

Toxic Metals Found in All Rice Samples in New Study

FRIDAY, May 16, 2025 — A new report says rice sold in U.S. stores contains toxic heavy metals, including arsenic, cadmium, lead and mercury. The...

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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