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FDA Acknowledges Astellas Pharma s Resubmission Of BLA For Zolbetuximab

TOKYO (dpa-AFX) - The U.S. Food and Drug Administration has acknowledged Astellas Pharma's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational

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Biogen: EU Approves Qalsody To Treat Rare, Genetic Form Of Amyotrophic Lateral Sclerosis

WESTON (dpa-AFX) - Biogen Inc. (BIIB) said that the European Commission has granted marketing authorization under exceptional circumstances and maintained orphan designation for Qalsody (tofersen)

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Regeneron: FDA Extends Review Period For Dupixent As COPD Treatment By Three Month

PARIS (dpa-AFX) - The U.S. Food and Drug Administration has extended by three months the target action date of its priority review of the supplemental Biologics License Application or sBLA for

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AbbVie: Risankizumab Recommended For EU Approval For Moderately-Severely Active Ulcerative Colitis

BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - AbbVie Inc. (ABBV) announced Friday that Friday that Risankizumab (SKYRIZI) has been recommended for European Union approval for the treatment of adults with

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Regeneron : FDA Extends Review Period For Dupixent As COPD Treatment By Three Month

(RTTNews) - The U.S. Food and Drug Administration has extended by three months the target action date of its priority review of the supplemental B.

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