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Results For "BLA"

264 News Found

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer
Drug Approval | January 29, 2024

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival


USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer
Drug Approval | January 10, 2024

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy


GlobalData predicts product cannibalization within electrophysiology ablation space
News | October 12, 2023

GlobalData predicts product cannibalization within electrophysiology ablation space

PFA technology is only marketed in Europe, and yet, it has been dominating the electrophysiology market by storm


Pfizer acquisition of ADC trailblazer Seagen a worthy investment: GlobalData
News | March 25, 2023

Pfizer acquisition of ADC trailblazer Seagen a worthy investment: GlobalData

Pfizer’s total cumulative revenue from Seagen therapies is expected to reach $36 billion by 2028, according to GlobalData, a leading data and analytics company.


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


Blacksmith announces merger with Forge Therapeutics
News | January 03, 2023

Blacksmith announces merger with Forge Therapeutics

To create leading company developing medicines targeting metalloenzymes


Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies
News | December 28, 2022

Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies

Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Evonik appoints Dr. Gaetano Blanda as Head of Animal Nutrition Business Line
People | September 08, 2022

Evonik appoints Dr. Gaetano Blanda as Head of Animal Nutrition Business Line

Blanda will be responsible for overseeing Evonik’s amino acids and functional feed additives business and the expansion of its precision livestock farming approach