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Results For "BLA"

275 News Found

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Drug Approval | April 02, 2024

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial


NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


Blacksmith Medicines and Zoetis collaborate for novel animal health antibiotics
News | February 17, 2024

Blacksmith Medicines and Zoetis collaborate for novel animal health antibiotics

Through our research, we aim to ultimately provide new options for our customers to treat life-threatening infections in livestock


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