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Results For "BLA"

275 News Found

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years


Aster Medcity Kochi launches Cryo-ablation procedure to tackle heart disease
Hospitals | November 05, 2021

Aster Medcity Kochi launches Cryo-ablation procedure to tackle heart disease

The process is completed with the help of a balloon at a low temperature so that other cells are undamaged and the patient can return home the next day


CDSCO approves Exablate 4000 for patients living with Parkinson’s disease
Medical Device | September 20, 2021

CDSCO approves Exablate 4000 for patients living with Parkinson’s disease

The approval will enable the treatment of patients in India living with Essential tremor, tremor-dominant Parkinson's Disease and neuropathic pain


Five manufacturers get license to produce Black Fungus drug
News | May 23, 2021

Five manufacturers get license to produce Black Fungus drug

NATCO Pharmaceuticals, Hyderabad; Alembic Pharmaceuticals, Vadodara; Gufic Biosciences Ltd., Gujarat; Emcure Pharmaceuticals, Pune; and Lyka, Gujarat are new manufacturers


Imfinzi granted Priority Review and Breakthrough Therapy Designation in US
News | July 31, 2025

Imfinzi granted Priority Review and Breakthrough Therapy Designation in US

For patients with resectable early-stage gastric and gastroesophageal junction cancers


Asahi Kasei Life Science to construct new plant for Planova virus removal filters
News | July 31, 2025

Asahi Kasei Life Science to construct new plant for Planova virus removal filters

The new facility will be the company’s fourth spinning plant for hollow-fiber cellulose membrane filters


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease


EU launches strategies to strengthen crisis readiness and health security
Policy | July 11, 2025

EU launches strategies to strengthen crisis readiness and health security

The Medical Countermeasures Strategy focuses on strengthening the EU’s preparedness for health crises


Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone


Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC
Diagnostic Center | June 02, 2025

Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC

First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC