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Mirum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI (chenodiol) tablets, a bile acid, for the treatment of adults with…
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Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy …
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Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and…
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Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced the availability of SELARSDI (ustekinumab-aekn) injection in the U.S., a biosimilar…
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Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment of…
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ImmunityBio, Inc. announced the U.S. Food and Drug Administration (FDA) has authorized an expanded access program (EAP) that will bring a vital alternative source of BCG, a…
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Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular…
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The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous…
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Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly…
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Biogen Inc. and Stoke Therapeutics, Inc. announced a collaboration for the development and commercialization of zorevunersen, a potential first-in-class disease modifying medicine in…
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