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Tag: America

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FDA Clears Tissue Repair Drug AD-NP1 For Clinical Trials

The FDA has granted approval to begin clinical trials of the AD-NP1 drug. It is a first-in-class drug for tissue regeneration, which targets cellular...

US FDA Launches Fast-Track Review Scheme for Generic Drugs

The FDA has introduced a pilot fast-track review programme aimed at accelerating reviews for generic medicines tested and manufactured within the United States, marking...

AbbVie Launches New API Manufacturing Facility in Illinois

AbbVie has started construction of a new active pharmaceutical ingredient (API) manufacturing facility in North Chicago, Illinois, a critical milestone in its strategy to...

Amgen to Expand U.S. Manufacturing with $650M Investment

Amgen has announced a $650 million expansion of its U.S. manufacturing facilities, a development that will create almost 750 new positions. The expansion will...

Lilly to Build $6.5B API Manufacturing Facility in Houston

Eli Lilly and Company has unveiled plans for a $6.5 billion manufacturing facility in Generation Park, Houston, Texas. The project, described as a next-generation...

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Building the Right Team and Resource Model to Support Quality System and Validation Activities

Since life science quality and validation projects can vary...

Merck and Blackstone Enter R&D Funding Agreement for sac-TMT

Merck, recognized as MSD outside the U.S. and Canada,...

FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

Johnson & Johnson said the U.S. Food and Drug...

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

UCB, a leading global biopharmaceutical company, has announced that...

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