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.
Tuesday, December 06, 2022
Roche announced the appointment of Brad Moore as president and CEO of Roche Diagnostics North America, effective January 1, 2023.
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Wednesday, December 07, 2022
The FDA is announcing the availability of a revised draft guidance for industry, ANDAs: Pre-Submission Facility Correspondence Related to Prioritized ...
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Thursday, December 08, 2022
Moleculin Biotech announced that the FDA granted Fast Track designation of WP1122 for the treatment of Glioblastoma Multiforme ("GBM").
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Monday, December 12, 2022
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the FDA for talquetamab...
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Monday, December 12, 2022
Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized COMIRNATY® Original & Omicron BA.4/BA.5 as a 10-µg booster dose for ...
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Monday, December 12, 2022
The U.S. Pharmacopeia (USP) announced the opening of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia as part of its launch of a ...
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Tuesday, December 13, 2022
ADMA Biologics, Inc. announced the FDA approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to now include...
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Thursday, December 15, 2022
AstraZeneca and MSD announced that the FDA informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date by three months to...
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Friday, December 16, 2022
Now in its 20th year! The bioindustry's most in-depth, global benchmarking and analysis study: Your input is important as we benchmark current global ...
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Thursday, December 29, 2022
Harm Reduction Therapeutics (HRT), Inc., a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making ...
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Tuesday, January 03, 2023
Blacksmith Medicines, Inc. and Forge Therapeutics have signed a definitive merger agreement to leverage their combined chemistry platforms, creating a...
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Wednesday, January 04, 2023
Checkpoint Therapeutics announced the submission of a Biologics License Application (BLA) to the FDA for the approval of cosibelimab, an ...
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Orchard Therapeutics announced the FDA cleared its Investigational New Drug (IND) application for OTL-203, a hematopoietic stem cell (HSC) gene ...
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Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the FDA accepted for review a Biologics ...
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UCB announced that the FDA accepted the company's filing to review a Biologic License Application (BLA) for its investigational treatment ...
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