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FDA General

Congress Should End Government Layoffs: Professor

Harvard University health policy professor Benjamin Sommers calls on Congress to stand up against cuts in the federal workforce that he says are hurti...

Animal Drugs

Prothena Scraps Birtamimab After Phase 3 Miss

Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...

Biologics

Covid Vaccine Nixed for Children/Pregnant Women

HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDCs recommended immunization schedule.

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Human Drugs

Gene Therapy Trial on Hold After Death

FDA places a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Danon disease, following...

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Medical Devices

FDA Clears Olympus Endoscope Series

FDA gives 510(k) clearance to the latest Olympus endoscopes that feature new extended depth of field technology.

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Human Drugs

Savara Gets Refusal-to-File Letter for Molbreevi BLA

FDA issues Savara a Refusal-to-File (RTF) letter for its BLA for Molbreevi (molgramostim) inhalation solution for treating autoimmune pulmonary alveol...

Animal Drugs

Interchangeability for Celltrions Humira Biosimilar Expanded

FDA grants an expanded interchangeable designation for Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

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Medical Devices

BD Recalls Esophagogastric Balloon Tamponade Tubes

BD recalls its Esophagogastric Balloon Tamponade Tubes to update the devices instructions for use due to difficulties in removing plastic plugs from i...

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Human Drugs

FDA Approves Liquidias Pulmonary Hypertension Drug

FDA approves Liquidias Yutrepia (Treprostinil), a new inhalation powder designed to treat adults with pulmonary arterial hypertension and pulmonary hy...

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Human Drugs

Susvimo Approved for Diabetic Retinopathy

FDA approves Roches Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy.