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
The inspection was carried out from January 28 to February 1, 2025
EBITDA grew by 11% on a YoY basis to Rs. 296 crore due to improved performance in CDMO Sterile Injectables, CRDMO and Generics
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
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
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.
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
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 operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
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
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
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