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843 News Found

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting


Merck and Moderna initiate Phase 3 study evaluating V940 (mRNA-4157) in combination with Keytruda for treatment of non-small cell lung cancer
News | December 12, 2023

Merck and Moderna initiate Phase 3 study evaluating V940 (mRNA-4157) in combination with Keytruda for treatment of non-small cell lung cancer

The initiation of the second clinical trial in the INTerpath program represents rapid expansion in research for additional tumor types for individualized neoantigen therapy, V940 (mRNA-4157)


Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto
Drug Approval | December 12, 2023

Merck Animal Health receives positive CVMP opinion for an injectable formulation of Bravecto

The CVMP recommends the product for approval for the treatment and persistent killing of fleas


Pfizer presents marstacimab Phase 3 Data at ASH 2023
News | December 10, 2023

Pfizer presents marstacimab Phase 3 Data at ASH 2023

Demonstrate significant bleed reduction in hemophilia A and B


Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis
Drug Approval | December 10, 2023

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections


European Commission approves Pfizer’s Elrexfio for multiple myeloma
Drug Approval | December 09, 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial


Zepbound is now available in US for adults living with obesity
News | December 09, 2023

Zepbound is now available in US for adults living with obesity

Express Scripts to add Zepbound to National Preferred Formulary


AbelZeta Pharma, AstraZeneca to co-develop a novel GPC3 armored CAR-T therapy in China
News | December 08, 2023

AbelZeta Pharma, AstraZeneca to co-develop a novel GPC3 armored CAR-T therapy in China

C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II


AstraZeneca discontinues Phase III trials of Stabilizer-CKD and Dialize-Outcomes
News | December 05, 2023

AstraZeneca discontinues Phase III trials of Stabilizer-CKD and Dialize-Outcomes

STABILIZE-CKD and DIALIZE-Outcomes trials are part of the CRYSTALIZE evidence programme


Strides launches Icosapent Ethyl Acid Soft Gel capsules in partnership with Amneal
News | December 02, 2023

Strides launches Icosapent Ethyl Acid Soft Gel capsules in partnership with Amneal

The product has been in-licensed from Strides and will be commercialized by Amneal