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
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA
The company has received marketing authorisation for docetaxel from Israel and cytarabine from Colombia
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
Venus Remedies' oncology wing has also secured marketing authorisation from Myanmar for another chemotherapy drug
The company has secured 506 marketing approvals for its oncology products across 76 countries.
With this, the number of marketing approvals for its oncology products across 75 countries has gone up to 503
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