Agios Pharmaceuticals Inc. is learning the hard way the downside of having a pipeline in a product. When a side effect crops up, investors are likely to worry that it may affect the potential of the drug in the numerous diseases the drug could potentially treat.
Enanta Pharmaceuticals Inc. hit the mark that Wall Street hoped for, and details rolled out in top-line results from the first-in-pediatrics phase II study evaluating once-daily, oral zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Epicentrx, Verrica, Torii.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Beacon, Biohaven, Biontech, Daiichi, Duality, Novartis, Urogen.
The FDA’s final guidance for predetermined change control plans (PCCPs) for AI products contains a number of editorial changes, some more significant than others.
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