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Results For "BLA"

275 News Found

Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Diagnostic Center | July 21, 2025

Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer
Diagnostic Center | July 06, 2025

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone


Imfinzi perioperative regimen improved survival across muscle-invasive bladder cancer patients
News | February 15, 2025

Imfinzi perioperative regimen improved survival across muscle-invasive bladder cancer patients

Imfinzi reduced the risk of distant metastases and death from bladder cancer vs. neoadjuvant chemotherapy alone


FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA


Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer
Diagnostic Center | January 13, 2025

Pfizer’s Sasanlimab in combination with BCG improves survival in patients with bladder cancer

If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population


Aster and Blackstone-backed Quality Care to merge and create hospital chains in India
Healthcare | December 04, 2024

Aster and Blackstone-backed Quality Care to merge and create hospital chains in India

Aster DM Healthcare and Quality Care India Limited have signed definitive agreements to merge, subject to regulatory, corporate and shareholders’ approvals


Imfinzi improved event-free survival and overall survival for bladder cancer
Diagnostic Center | June 26, 2024

Imfinzi improved event-free survival and overall survival for bladder cancer

First immunotherapy regimen before and after surgery to extend survival in bladder cancer


LVPEI raises awareness and funds for retinoblastoma treatment with WHITATHON Run
Healthcare | May 20, 2024

LVPEI raises awareness and funds for retinoblastoma treatment with WHITATHON Run

The funds raised from the Whitathon run are utilized to treat underprivileged children suffering from Retinoblastoma