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.
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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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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FDA is announcing the availability of a final guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.”
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Novavax, Inc. and Serum Institute of India Pvt. announced that the Thailand Food and Drug Administration (Thai FDA) has granted emergency use ...
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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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Clayton Pharmaceuticals has received FDA approval for Sucralfate Oral Suspension with Competitive Generic Therapy (CGT) designation.
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Wednesday, April 06, 2022
Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA....
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Wednesday, April 06, 2022
Bristol Myers Squibb announced that the European Commission (EC) has granted Marketing Authorization for Breyanzi (lisocabtagene maraleucel; liso-cel)...
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Regeneron Pharmaceuticals, Inc. and Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental ...
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Curis, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the Company's TakeAim Leukemia Phase 1/2a...
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Precigen, Inc. announced that the FDA has granted Fast Track designation for PRGN-3006 UltraCAR-T® in patients with relapsed or refractory (r/r) AML (...
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