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FDA Approves Gamifant (emapalumab-lzsg) as First-Ever Treatment for Adults and Children with Macrophage Activation Syndrome in Still's Disease

Sobi today announced that the U.S. Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for the treatment of adult and pediatric...

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...

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)...

Close to 150,000 Pounds of Ready-to-eat Bologna Recalled Due to Mislabeling

MONDAY, June 30, 2025 — Gaiser's European Style Provisions Inc. is recalling almost 150,000 pounds of ready-to-eat bologna due to mislabeling.The recalled...

Capsule Sponge + Biomarkers Can Stratify Risk in Barrett Esophagus

In adult patients with nondysplastic Barrett esophagus at last endoscopy, a subsequent capsule-sponge test can assist in identifying those at highest risk...

Experts Sound Alarm About Risk of Child Deaths in Hot Cars

MONDAY, June 30, 2025 — With  early summer temperatures already setting triple-digit records across the East Coast, safety experts are sounding...

Late-Life Mood Disorders May Indicate Predisposition to Dementia

Alzheimer disease (AD) and diverse non-AD tau pathologies may contribute to late-life mood disorders (LLMDs), according to a study published online June...

Muscle Ultrasound Can Detect Insulin Resistance

Muscle ultrasound can detect insulin resistance and lower muscle mass, according to a study published online June 12 in the Journal of Ultrasound Medicine. Steven...

AAP Offers Guidance for Genetic Evaluation of Neurodevelopmental Disorders

In a clinical report issued by the American Academy of Pediatrics and published online June 23 in Pediatrics, guidance is provided for the pediatrician...

Nestle, Other Food Companies Vow to Ban Artificial Colors

MONDAY, June 30, 2025 — Nestle has joined a growing list of major food companies pledging to voluntarily eliminate artificial colors from their U.S....

'Pill-On-A-String' Could Revolutionize Testing For Throat Cancer

MONDAY, June 30, 2025 — The thought of swallowing a pill on a thread isn’t the most pleasant notion, but it could be a vastly better alternative...

Body Fat Analysis, Waist Size Better Than BMI For Assessing Health

FRIDAY, June 27, 2025 — A person’s body fat percentage provides a better estimate of their risk for early death than their body mass index...

Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation

SEATTLE and VANCOUVER, British Columbia, June 26, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage specialty pharmaceutical...

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...

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...

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 in adult...
  • 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...

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