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DDF Summit 2025

Tag: America

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U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets

Janssen Pharmaceuticals, Inc one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today that the U.S. Food and Drug Administration (FDA)...

Cepheid Announces WHO Prequalification Of Xpert HIV-1 Qualitative Test

Cepheid announced that its Xpert® HIV-1 Qual test has been awarded WHO prequalification, making it one of the first molecular point of care tests...

FDA Panel To Review the Amgen’s ABP 501, Biosimilar Candidate To Adalimumab

Amgen announced that the Arthritis Advisory Committee of the U.S. FDA will review data supporting the Company's Biologics License Application (BLA) for ABP 501,...

Eisai presents data on its anti-fractalkine monoclonal antibody E6011

Eisai Co Ltd. announced that interim analyses on the latest data for the world's first anti-fractalkine monoclonal antibody E6011, discovered by Eisai's research subsidiary...

Merck, Pfizer double size of diabetes study to catch rivals

Merck in partnership with Pfizer Inc. announced that two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor...

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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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