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FDA Approves Benlysta (belimumab) Autoinjector for Children with Active Lupus Nephritis
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab),...
Datroway Approved in the U.S. as First TROP2 Directed Therapy for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Tokyo and Basking Ridge, NJ – June 23, 2025 – Datroway (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult...
Dupixent (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP)
TARRYTOWN, N.Y. and PARIS, June 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today...
FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria
BOSTON, Massachusetts and Cambridge, UK – June 19, 2025 – Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone)...
Riliprubart Earns Orphan Drug Designation in the US for Antibody-Mediated Rejection in Solid Organ Transplantation
Paris, June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of...
Differences in Life Expectancy Underestimated for Indigenous Americans
Large differences in life expectancy between American Indian/Alaska Native (AI/AN) individuals versus other U.S. residents have been underestimated, according...
Telehealth Intervention Beneficial for Seniors With Metastatic Cancer
The telehealth-administered Geriatric Assessment–Guided Intervention (GAIN-S) improves physical function, mood, quality of life, and prognostic understanding...
Pacers’ Tyrese Haliburton Tears Achilles in Game 7 of NBA Finals
WEDNESDAY, June 25, 2025 — Indiana Pacers star Tyrese Haliburton tore his right Achilles tendon during the team’s loss in Game 7 of the NBA...
Texas Governor Blocks THC Ban, Keeping Gummies and Vapes Legal
WEDNESDAY, June 25, 2025 — THC-infused gummies and vape pens will stay legal in Texas — at least for now. Gov. Greg Abbott vetoed a bill on...
Insurers Promise to Speed Up Delays in Health Care Approvals
WEDNESDAY, June 25, 2025 — Getting approval from your insurance company before a procedure or treatment may soon get a little easier. U.S. Health...
Monthly Obesity Shot, MariTide, Shows Big Weight Loss in Trial
WEDNESDAY, June 25, 2025 — Alternatives to weekly injections of weight-loss drugs may on the way. A monthly dose of a new drug called MariTide helped...
ADA: Weight Loss, Type 2 Diabetes Remission Up With Replacing Diet Drinks With Water
For adult women with overweight or obesity and type 2 diabetes (T2D), replacing diet beverages (DBs) with water is associated with greater weight loss...
Desogestrel for More Than Five Years May Up Risk of Intracranial Meningioma
Women who have used the oral contraceptive desogestrel (75 µg) for more than five continuous years have a small increased risk of intracranial meningioma,...
FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
FDA Safety Communication June 25, 2025 Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing...
Brain Age Gap May Mediate Influence of Cognitive Impairment Risk Factors
The brain age gap (BAG) plays a role in mediating the influence of cognitive impairment risk factors on cognitive function, especially among individuals...
Drug Safety Communication: FDA Investigating Deaths Due to Acute Liver Failure in Non-Ambulatory Duchenne Muscular Dystrophy Patients Following Elevidys
Since approval, the Food and Drug Administration (FDA) has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric...
Studies Address Muscle Loss Caused By GLP-1 Drugs, such as Ozempic and Zepbound
TUESDAY, June 24, 2025 — GLP-1 drugs like Ozempic and Zepbound are great at promoting weight loss, but they also cause folks to lose muscle along...
Nuvalent Announces Positive Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-Positive NSCLC
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically...
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Latest FDA New Drug Approvals
- Harliku Harliku (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid (HGA) in...
- Yeztugo Yeztugo (lenacapavir) is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor for pre‑exposure prophylaxis (PrEP) to reduce the r...
- Andembry Andembry (garadacimab-gxii) is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks...