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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...

Incyte Announces Additional FDA Approval of Opzelura (ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis

(BUSINESS WIRE)--Sep. 18, 2025-- Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved...

Nonatherothrombotic Causes Account for Much of MI Burden in Younger Adults

For persons aged 65 years and younger, nonatherothrombotic causes comprise a considerable burden of acute myocardial infarction (MI), according to a study...

Repetitive Head Impact Exposure Tied to Disruption at Depths of Sulci

Higher repetitive head impact (RHI) exposure is associated with microstructural disruption at the depths of sulci, according to a study published online...

Shunt Surgery Beneficial in Idiopathic Normal-Pressure Hydrocephalus

Shunt surgery significantly improves gait velocity at three months among patients with idiopathic normal-pressure hydrocephalus with a response to temporary...

GLP-1 Receptor Agonists Improve Glycemic, Weight Outcomes in Children With T2D

In children and adolescents with type 2 diabetes (T2D) or obesity, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) improve glycemic, weight, and...

Kroger and AquaStar Recall 85,000+ Bags of Shrimp Over Radiation Risk

TUESDAY, Sept. 23, 2025 — More than 85,000 bags of frozen shrimp sold under Kroger and AquaStar brands have been recalled because of possible contamination...

Teen Develops Rare Vaginal Cancer Typically Found In Older Women

TUESDAY, Sept. 23, 2025 — Liliana “Lili” Casteneda had what she thought was her first period at the age of 14, during the height of the COVID-19...

FDA to Approve New Use of Cancer Drug for Autism Symptoms in Kids

TUESDAY, Sept. 23, 2025 — A decades-old cancer drug may soon be approved to help kids with certain autism-related symptoms linked to folate deficiency.The...

Trump Links Tylenol, Vaccines to Autism Without Evidence, Experts Say

TUESDAY, Sept. 23, 2025 — President Donald Trump on Monday linked autism to acetaminophen use in pregnancy and vaccines — claims that scientists say...

Ionis Announces Positive Topline Results From Pivotal Study of Zilganersen in Alexander Disease

(BUSINESS WIRE)--Sep. 22, 2025-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results from the pivotal study of...

Johnson & Johnson’s Investigational Seltorexant Shows Numerically Higher Response in Patients with Depression with Insomnia Symptoms, with Fewer Side Effects Compared to Quetiapine XR

TITUSVILLE, NJ. (September 22, 2025) – Johnson & Johnson announced results from the Phase 3 MDD3005 26-week clinical trial evaluating the...

Three Health Conditions Raise Death Risk For Fatty Liver Disease

FRIDAY, Sept. 19, 2025 — People with fatty liver disease are more likely to die early if they have one of three additional health problems, a new...

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

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Latest FDA New Drug Approvals

  • 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.
  • Enbumyst Enbumyst (bumetanide) nasal spray is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic...

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