Pharma Journalist -

Andelyn Biosciences, Inc., a leading contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, has announced a new partnership with Amplo…
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Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema…
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Keros Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to KER-065 for the treatment of Duchenne muscular dystrophy (DMD), a…
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Jazz Pharmaceuticals plc and Saniona have entered into a global licensing agreement granting Jazz exclusive worldwide rights to develop and commercialize SAN2355, a subtype-selective…
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Crinetics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to atumelnant, its once-daily oral ACTH receptor…
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Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes Inc. to produce the drug substance for AnGes' investigational Hepatocyte Growth Factor…
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PTC Therapeutics, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for vatiquinone, a…
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Santen Pharmaceutical Co., Ltd. has announced a new licensing agreement with Chinese biopharmaceutical company RemeGen Co., Ltd. to exclusively develop, manufacture, and commercialize…
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Madrigal Pharmaceuticals, Inc. has received conditional marketing authorization from the European Commission (EC) for Rezdiffra (resmetirom), making it the first and only approved…
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SpringWorks Therapeutics, part of Merck KGaA, Darmstadt, Germany, announced that the European Commission (EC) has granted marketing authorization for OGSIVEO (nirogacestat), an oral…
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