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2089 News Found

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)


Sigachi Industries to invest US $1 mn in establishing R&D Centre in Hyderabad
News | February 04, 2025

Sigachi Industries to invest US $1 mn in establishing R&D Centre in Hyderabad

The company is committed to revolutionizing API development by advancing synthesis and analytical processes that enhance quality and impact lives


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
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


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


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


Biocon’s S&P Global ESG Score improves to 69 for 2024
Sustainability | January 30, 2025

Biocon’s S&P Global ESG Score improves to 69 for 2024

Biocon’s subsidiary Biocon Biologics Limited, which also participated independently in the assessment for the first time, reported an S&P Global ESG Score of 53


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