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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...

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)...

Ex-Vaccine Panelist Speaks Out on Firing, New Committee

Thursday, June 26, 2025 — The federal Advisory Committee on Immunization Practices (ACIP) has been soberly and deliberately helping set U.S. vaccination...

CRC as First of Multiple Primary Malignancies Tied to Better Outcomes Than CRC as Only Malignancy

Compared with colorectal cancer (CRC) presenting as an isolated primary or second primary malignancy, CRC presenting as the first of multiple primary malignancies...

Empagliflozin Has Kidney Protective Effects in Acute Myocardial Infarction

Empagliflozin has kidney protective effects and reduces heart failure outcomes across baseline kidney function among patients with acute myocardial infarction...

Arsenic Less Than EPA Maximum Contaminant Level Tied to Adverse Birth Outcomes

Arsenic measured in public water systems at levels below the current U.S. Environmental Protection Agency's maximum contaminant level are associated with...

Moderate-to-Severe Asthma Up for Female Permanent Night Shift Workers

Female permanent night shift workers have higher odds of moderate-to-severe asthma than female day workers, but this relationship is not seen in men, according...

CDC Pulls Vaccine Slide After Expert Cites Study Doesn’t Exist

THURSDAY, June 26, 2025 — A presentation scheduled for a U.S. Centers for Disease Control and Prevention (CDC) vaccine meeting today claimed that...

Senate Grills CDC Nominee Susan Monarez on Agency Cuts

THURSDAY, June 26, 2025 —  The woman tapped to lead the U.S. Centers for Disease Control and Prevention (CDC) says she supports science, vaccines...

NIH Stops Canceling Research Grants Following Court Ruling

THURSDAY, June 26, 2025 — The National Institutes of Health (NIH) has stopped canceling biomedical research grants after a federal judge said hundreds...

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...

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...

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