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The FDA has granted priority review to Eisai’s and Biogen’s supplemental biologics license application (sBLA) for their Alzheimer’s treatment candidate Leqembi (lecanemab-irmb), supporting the biologic’s conversion from Accelerated Approval (AA) to traditional approval. Read More
The FDA has said no to Cytokinetics’ new drug application (NDA) for omecamtiv mecarbil, an investigational treatment for heart failure with reduced ejection fraction (HFrEF). Read More
The European Medicines Agency’s (EMA) human medicines committee has endorsed eight new drugs for approval following its February monthly meeting. Read More
The FDA has granted Fast Track designation to Icosavax’s IVX-A12, an innovative investigational bivalent vaccine that targets both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). Read More