News

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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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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GSK announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for gepotidacin, an oral antibiotic, for the treatment of…
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Sartorius Stedim Biotech, a leading provider of solutions for the biopharmaceutical industry, has announced a new strategic partnership with Nanotein Technologies, a California-based…
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Arvinas, Inc., in partnership with Pfizer, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, a novel oral…
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Ono Pharmaceutical Co., Ltd. announced that it has entered into a definitive agreement with Seikagaku Corporation to co-develop and exclusively market Gel-One, Seikagaku’s…
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CorMedix Inc. and Melinta Therapeutics LLC announced a definitive agreement for CorMedix to acquire Melinta. The selling shareholders will receive $300 million in total consideration at…
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Valneva SE announced that the U.S. Food and Drug Administration (FDA) has lifted its previously recommended pause on the use of the company’s Chikungunya vaccine, IXCHIQ, in individuals…
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