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Results For "BLA"

301 News Found

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


Nuvectis announces positive data for NXP900 in a preclinical model of Group 4 medulloblastoma
News | June 14, 2022

Nuvectis announces positive data for NXP900 in a preclinical model of Group 4 medulloblastoma

Group 4 Medulloblastoma is a rare disease that mostly affects pediatric patients, in which aberrant SRC signaling was identified as a hallmark of the disease


Urologists explore the role of robotics, equity, exercise and medicine on bladder cancer
Healthcare | May 16, 2022

Urologists explore the role of robotics, equity, exercise and medicine on bladder cancer

Researchers presented these bladder cancer study findings at the 117th Annual Scientific Meeting of the American Urological Association (AUA)


USFDA seeks more analysis on Merck’s BLA for Vaxneuvance
Biotech | April 01, 2022

USFDA seeks more analysis on Merck’s BLA for Vaxneuvance

No new studies have been requested


Bronchoscopic Thermal Vapor Ablation (BTVA): A new ray of hope for COPD patients
Hospitals | March 31, 2022

Bronchoscopic Thermal Vapor Ablation (BTVA): A new ray of hope for COPD patients

Yashoda Hospitals Hyderabad has earned the distinction of becoming the first to introduce BTVA in India