Food and Drug Administration (FDA)
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The FDA further delays Iovance’s filing for its TIL therapy as it requests additional data on the treatment’s potency assays.
BMS inked a collaboration agreement with Exscientia that can leverage AI to speed the discovery of drug candidates in therapeutic areas, including oncology and immunology.
The U.S. FDA scolded CytoDyn for misrepresenting its clinical trial results for Leronlimab in COVID-19. Here’s what FDA has to say regarding CytoDyn Leronlimab.
The high court’s decision will prevent Sandoz from launching its biosimilar to Amgen’s blockbuster rheumatoid arthritis drug.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 18, 2021.
The guidance takes effect immediately and will remain in effect throughout the pandemic.
A recent Phase II trial show Regeneron’s monoclonal antibody evinacumab significantly reduced fasting triglycerides in patients with severe hypertriglyceridemia.
Empaveli (pegcetacoplan) is the first and only targeted C3 therapy for the treatment of adults with PNH, the Waltham, Mass.-based company said in its announcement.
Humanigen reported it had held a meeting with the FDA to discuss plans for filing an EUA for its lenzilumab for hospitalized, hypoxic COVID-19 patients by the end of May.
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