Tag: Breakthrough Therapy Designation

FDA Grants Breakthrough Therapy Designation to Olomorasib for Advanced Pancreatic Cancer

The U.S. FDA has granted Breakthrough Therapy designation to Lilly's investigational KRAS…

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Major Acquisition to Advance Therapies for Treatment-Resistant Depression

Lilly will acquire AtaiBeckley in a deal valued at up to $3.8…

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FDA Grants Priority Review for GSKโ€™s Bepirovirsen for Chronic Hepatitis B

The FDA has granted Priority Review to GSKโ€™s bepirovirsen for chronic hepatitis…

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FDA Grants Breakthrough Therapy Designation to Novartisโ€™ Ianalumab for Sjรถgrenโ€™s Disease

The FDA has granted Breakthrough Therapy designation to Novartisโ€™ ianalumab for Sjรถgrenโ€™s…

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Yeztugo by Gilead Gets FDA OK, Promises Easier HIV Prevention

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA)…

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