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Animal Drug Regs Amended to Reflect Approvals

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions animal drug applications ap...

Boehringer Reports Gains on Liver Disease Candidate

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Boehringer Ingelheim reports data from its Phase 2 survodutide study showing that up to 83.0% of adults treated with the drug achi...

After 2 Earlier Denials, Humira Biosimilar OKd

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FDA approves Alvotech and Teva Pharmaceuticals Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVies Humi...

Rybrevants Regulatory Review Period Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Janssen Biotechs Rybrevant ...

New App for Reporting Drug Amounts Produced

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FDA creates a new CARES Act Amount Information Reporting application for drug establishments to use when submitting (xxx insert, d...

NY Attorney General Urges FDA Action on Singulair

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New York attorney general Letitia James urges FDA to take further safety actions to address the dangers of Mercks Singilair (monte...

BrainStorm Seeks Special Protocol for ALS Treatment

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BrainStorm Cell Therapeutics files a Special Protocol Assessment request for a Phase 3b study of NurOwn, its investigational treat...

Dupixent sBLA Get Priority Review for COPD

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FDA accepts for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatmen...

Venatorx/Melinta Antibiotic Gets Complete Response

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FDA issues Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a...

Bioporto Pediatric Kidney Injury Assay Cleared

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FDA clears a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury.