Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 7

Results For "BLA"

301 News Found

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
Clinical Trials | 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


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance


Merck KGaA, Darmstadt, Germany, Showcases Innovation at ASCO 2025
News | May 23, 2025

Merck KGaA, Darmstadt, Germany, Showcases Innovation at ASCO 2025

Merck KGaA, Darmstadt, Germany announced the presentation of new oncology data across more than 12 tumor types at ASCO 2025


FUJIFILM India to sell Spectra Logic’s tape storage products, software in India
News | April 25, 2025

FUJIFILM India to sell Spectra Logic’s tape storage products, software in India

Distribution agreement enables FUJIFILM India to offer Spectra Logic advanced tape libraries and software solutions to enterprise customers and channel partners


Eugia Pharma receives USFDA approval for Dasatinib Tablets
Drug Approval | April 24, 2025

Eugia Pharma receives USFDA approval for Dasatinib Tablets

Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia