Pharma Journalist -

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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SystImmune Inc. and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan…
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Boehringer Ingelheim and Palatin Technologies, Inc. have announced a global research collaboration and licensing agreement to develop a novel treatment targeting retinal diseases. This…
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Precigen, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to PAPZIMEOS (zopapogene imadenovec-drba), the first and only FDA-approved treatment…
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Kexing Biopharm has announced a strategic partnership with IQVIA, a global leader in clinical research and healthcare intelligence, to accelerate the international development and…
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Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Iron Sucrose Injection, USP, the first generic version of Venofer Injection. This intravenous…
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The U.S. Food and Drug Administration (FDA) has granted accelerated approval to HERNEXEOS (zongertinib tablets), Boehringer Ingelheim’s new oral targeted therapy for adults with…
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