Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 58

Results For "NDA"

4222 News Found

Syngene International expands capabilities with new bioconjugation suite in Bengaluru
News | October 25, 2025

Syngene International expands capabilities with new bioconjugation suite in Bengaluru

Bioconjugation capability to complement commercial payload, linker, and monoclonal antibody services


Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study
Clinical Trials | October 25, 2025

Sanofi’s Efdoralprin Alfa shows superiority in phase 2 Alpha-1 antitrypsin deficiency study

Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy


Europe is putting vital medicines at risk by allowing ‘carbon heavy’ imports from the Far East: INEOS
News | October 25, 2025

Europe is putting vital medicines at risk by allowing ‘carbon heavy’ imports from the Far East: INEOS

INEOS production of BDO in Germany, which produces a vital ingredient for antibiotics, statins and vitamin B6, is being crushed by a flood of carbon heavy imports and product dumping from the Far East


AstraZeneca's imfinzi cuts death risk by 22% in early gastric cancer
Clinical Trials | October 24, 2025

AstraZeneca's imfinzi cuts death risk by 22% in early gastric cancer

OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy


IMCD showcases patient-centric pharmaceutical solutions at CPHI Frankfurt 2025
News | October 24, 2025

IMCD showcases patient-centric pharmaceutical solutions at CPHI Frankfurt 2025

The company’s “greener” initiatives emphasize eco-friendly excipients and energy-efficient manufacturing processes that reduce environmental impact without compromising product quality


Biocon Biologics secures Health Canada nod for biosimilars Yesintek, Yesintek IV
News | October 23, 2025

Biocon Biologics secures Health Canada nod for biosimilars Yesintek, Yesintek IV

Yesintek and Yesintek I.V. are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients


ACG to invest $200 million in US hard-shell capsule manufacturing
News | October 22, 2025

ACG to invest $200 million in US hard-shell capsule manufacturing

The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta


FDA approves Roche’s kidney inflammation drug
Drug Approval | October 22, 2025

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study


AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer
Clinical Trials | October 22, 2025

AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer

Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone


Enzalutamide leads to 40% lower risk of death in prostate cancer
Clinical Trials | October 22, 2025

Enzalutamide leads to 40% lower risk of death in prostate cancer

XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting