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.
The Precision Cancer Consortium (PCC) announced its formation as a new collaboration of pharmaceutical companies with a shared vision of enabling ...
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Wednesday, April 13, 2022
Direct Biologics announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine ...
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Wednesday, April 13, 2022
Longeveron Inc. announced a Cooperative Research and Development Agreement (CRADA) with the United States Department of Veterans Affairs (VA) for the ...
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Wednesday, April 13, 2022
Autigen, a biotechnology portfolio company of the pharmaceutical accelerator, Ascend BioVentures, has signed a research collaboration and license ...
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Wednesday, April 13, 2022
Novavax, Inc. announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization (CMA) for ...
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Valneva SE announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing ...
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Merck announced that V116, the company’s investigational 21-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from ...
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Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months its review of the Biologics ...
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The FDA has published Manual of Policies and Procedures (MAPP) 5240.10, “Classifying Approved New Drug Products and Drug-Device Combination Products ...
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Health Canada authorized Evusheld (tixagevimab and cilgavimab) for the prevention of COVID-19. After a thorough and independent scientific review of ...
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical ...
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Nektar Therapeutics and Bristol Myers Squibb announced that based on results from pre-planned analyses of two late-stage clinical studies of ...
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Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a treatment for adult patients ...
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Takeda has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid® Intramuscular ...
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AstraZeneca and Daiichi Sankyo received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab ...
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