The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Monday, November 14, 2022
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the ...
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Tuesday, November 15, 2022
Ashland announced the(FDA Center for Drug Evaluation and Research Office of New Drugs has accepted Ashland Viatel™ bioresorbable mPEG-PDLLA ...
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Tuesday, November 15, 2022
The FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may ...
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Thursday, November 17, 2022
Regeneron Pharmaceuticals, Inc. and CytomX Therapeutics, Inc. announced a collaboration and licensing agreement to create conditionally-activated ...
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Thursday, November 17, 2022
Takeda announced that the randomized, Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly-diagnosed ...
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Monday, November 21, 2022
Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) ...
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Monday, November 21, 2022
Takeda Canada announced that TAKHZYRO (lanadelumab), the first approved monoclonal antibody for the treatment of Hereditary Angioedema (HAE) has been ...
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Monday, November 21, 2022
Genmab A/S announced that the FDA accepted for Priority Review the Biologics License Application (BLA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20...
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Wednesday, November 23, 2022
Triastek, Inc. has received clearance for its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) to ...
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Wednesday, November 23, 2022
Takeda announced that the FDA accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company’s ...
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Wednesday, November 23, 2022
Ascletis Pharma Inc. announced that the FDA approved the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate ...
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Wednesday, November 23, 2022
The U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the ...
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Tuesday, November 29, 2022
Bristol Myers Squibb Canada (BMS) announced that Health Canada has approved SOTYKTU (deucravacitinib tablets), the first-in-its-class oral tablet for ...
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Tuesday, November 29, 2022
Immutep Limited has signed a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer for a new Phase I ...
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Thursday, December 01, 2022
Novavax, Inc. announced that the World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL) for Nuvaxovid™ (NVX-CoV2373) COVID-...
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