Pharma Journalist -

Disc Medicine said the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for its New Drug Application seeking approval of bitopertin to treat erythropoietic…
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PTC Therapeutics has withdrawn its resubmitted New Drug Application for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy after receiving review feedback from…
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China-based biotech developer Shanghai Ark Biopharmaceutical Co., Ltd. has received clearance from the U.S. Food and Drug Administration to begin a U.S. clinical study of its…
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French pharmaceutical group Sanofi announced a leadership transition after its board decided not to renew the mandate of Chief Executive Officer Paul Hudson. His final day leading the…
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Biotechnology company Amgen has received authorization from the European Commission for UPLIZNA as an add-on therapy for adults with generalized myasthenia gravis (gMG) who test…
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Pharmaceutical giant Merck & Co., Inc. — known internationally as MSD — has received U.S. regulatory approval for expanded use of its immunotherapy KEYTRUDA and the newer…
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Cancer-focused biotechnology company Citius Oncology, Inc. has entered an exclusive distribution agreement with international healthcare services group Uniphar to expand patient access…
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Biopharmaceutical company Madrigal Pharmaceuticals, Inc. has signed an exclusive global licensing agreement with Suzhou Ribo Life Science Co. Ltd. and its subsidiary Ribocure…
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Private equity firm Ampersand Capital Partners has announced the acquisition of contract development and manufacturing provider Purna Pharmaceuticals, signaling a strategic move to…
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A new collaboration between U.S. cell-therapy manufacturer Kincell Bio and biotechnology innovator RegCell aims to accelerate the clinical development of a next-generation…
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