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
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.
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
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
Morepen Laboratories approves hiving off of medical devices business
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
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