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3155 News Found

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Diagnostic Center | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma
News | February 01, 2025

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population


Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year


OneSource receives EIR with VAI classification from USFDA for BLD facility
Drug Approval | January 29, 2025

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies


Toray develops membrane doubling filtration for biopharmaceutical manufacturing processes
News | January 28, 2025

Toray develops membrane doubling filtration for biopharmaceutical manufacturing processes

The company will initially supply prototypes to diverse customers to evaluate in purification processes for producing gene therapy drugs with a view to swift commercialization


Emcure Pharmaceuticals inaugurates R&D centre in Ahmedabad
News | January 24, 2025

Emcure Pharmaceuticals inaugurates R&D centre in Ahmedabad

The Emcure Research Centre (ERC) will drive research across multiple dosage forms, including OSD, injectables, novel drug delivery systems (NDDS), inhalers and topical and transdermal formulations


Syngene reports 18% jump in Q3 FY25 PAT at Rs. 131 Cr
News | January 24, 2025

Syngene reports 18% jump in Q3 FY25 PAT at Rs. 131 Cr

Reported revenue from operations up by 11% to Rs. 944 crores Reported PAT (after exceptional items) up by 18% to Rs. 131 crore


Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr
News | January 23, 2025

Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr

The revenue from operations in Q3 FY25 is Rs. 8,358.6 crore, up 16% YoY