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Jazz Pharmaceuticals Signs Exclusive Licensing Deal with Saniona for SAN2355 Development

Aug 22, 2025
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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FDA Grants Orphan Drug Designation to Crinetics’ Atumelnant for Congenital Adrenal Hyperplasia

Aug 22, 2025
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, AnGes Ink Manufacturing Deal for HGF Gene Therapy

Aug 20, 2025
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 Gets FDA Complete Response Letter for Vatiquinone NDA

Aug 20, 2025
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, RemeGen Ink Licensing Deal for Dual-Target Eye Drug RC28-E

Aug 20, 2025
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’s Rezdiffra Approved in EU for MASH Treatment

Aug 20, 2025
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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European Commission Approves OGSIVEO for Adult Desmoid Tumors

Aug 19, 2025
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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FDA Grants Breakthrough Status to Izalontamab Brengitecan for EGFR-Mutant Lung Cancer

Aug 19, 2025
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, Palatin Technologies Partner to Develop Melanocortin Receptor Therapy for…

Aug 18, 2025
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’s PAPZIMEOS Gets Full FDA Approval for Recurrent Respiratory Papillomatosis

Aug 18, 2025
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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