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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...

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Human Drugs

Susvimo Approved for Diabetic Retinopathy

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

Biologics

FDA Backs Covid JN.1-Lineage for Next Boosters

FDA advises Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially using the LP.8.1 Co...

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Human Drugs

Promising Trodelvy Data in Breast Cancer: Gilead

Gilead Sciences reports promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with first-lin...

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FDA General

Judge Blocks Mass Federal Layoffs Pending Appeal

A federal judge extends by two weeks a preliminary injunction halting the Trump administrations plans for further reductions in force at FDA and 21 ot...

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.