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2717 News Found

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


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


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


Biocon posts Q3 FY25 PAT at Rs. 25 Cr
News | January 31, 2025

Biocon posts Q3 FY25 PAT at Rs. 25 Cr

The group reported Q3FY25 operating revenue of Rs 3,821 crore, driven by sustained double-digit growth of 14 per cent in biosimilars


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


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


Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer
News | January 27, 2025

Pfizer’s BRAFTOVI combination demonstrates improved response for mutant metastatic colorectal cancer

BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation