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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...

Adherence to Safe Sleep Practices Declines During, After Infant Illness

Reported adherence to safe sleep practices appears to be low among caregivers of infants presenting to the emergency department for low-acuity illness...

Cocoa Extract Supplementation Yields Significant Reduction in hsCRP

Cocoa extract supplementation yields a significant reduction in high-sensitivity C-reactive protein (hsCRP) and an increase in interferon-γ (IFN-γ),...

Poverty, Social Disadvantage Linked to Lower Fecundability

Poverty, low educational level, and household income are associated with lower fecundability and subfertility, according to a study published online Sept....

Low Metastasis Rate Seen for Radiation Plus Silicone Oil in Uveal Melanoma

Patients with uveal melanoma mainly treated with plaque brachytherapy with vitrectomy and silicone oil for radiation attenuation have low rates of metastases,...

Drug-Resistant 'Nightmare Bacteria' Infections Soar 70% in U.S.

WEDNESDAY, Sept. 24, 2025 — Infections caused by bacteria that no longer respond to many antibiotics are climbing at an alarming pace in the U.S., new...

Fish Oil May Raise or Lower Colon Cancer Risk, Depending on Your Genes

WEDNESDAY, Sept. 24, 2025 — About 19 million U.S. adults take fish oil supplements, often to protect against chronic diseases. But new research suggests...

Illinois Confirms First Case of Rare Tick-Borne Powassan Virus

WEDNESDAY, Sept. 24, 2025 — Illinois health officials are warning residents to be on alert after the state’s first case of Powassan virus was confirmed...

Mammograms May Still Save Lives for Women in Their 80s, Study Finds

WEDNESDAY, Sept. 24, 2025 — Though most guidelines recommend mammograms up to age 74, new research suggests they can be valuable for women in their...

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...

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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