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8420 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


Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US
News | December 12, 2023

Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US

The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome


Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873
News | December 12, 2023

Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873

The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe


ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346
News | December 10, 2023

ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346

First published clinical trial using live biotherapeutic candidate in Covid-19 patients suggests role in improving outcomes


Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories
News | December 10, 2023

Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories

Dr. Reddy's Laboratories has been issued a Form 483 with three observations


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


Aptar Pharms opens new production facility at Taloja, Mumbai
News | December 10, 2023

Aptar Pharms opens new production facility at Taloja, Mumbai

New facility is part of Aptar Pharma’s global expansion program


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