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1685 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


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


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


Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
Drug Approval | December 09, 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment


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


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions