FDA
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Shares of Portola Pharmaceuticals are falling after the company announced a delay of several months for possible regulatory approval of its Factor Xa-inhibitor antidote, AndexXa.
The U.S. Food and Drug Administration stunned the company with a Refusal to File letter regarding its New Drug Application (NDA) for multiple sclerosis treatment ozanimod.
Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections.
The U.S. Food and Drug Administration (FDA) has granted Shire’s Biologics License Application (BLA) for lanadelumab (SHP643) priority review.
Novartis is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration.
The U.S. Food and Drug Administration (FDA) granted San Diego-based Evofem Biosciences Fast Track designation for Amphora vaginal gel to prevent urogenital chlamydia infection in women.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC).
Despite the recent dismal news regarding Alzheimer’s drug development, the U.S. Food and Drug Administration (FDA) recently proposed new guidelines for developing drugs for the disease.
Janssen got a little love from the FDA on Wednesday.