Venus Remedies' oncology wing has also secured marketing authorisation from Myanmar for another chemotherapy drug
The launch of Elores in Ecuador is expected to open the doors for the entry of the novel antibiotic adjuvant entity in other important Latin American countries
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
Kivo’s expanded platform brings compliant collaboration and intelligent process automation to emerging Regulatory, Clinical and Quality teams
The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA)
In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs
Amgen will be prohibited from leveraging its drug portfolio to disadvantage rivals and will be required to seek prior approval before acquiring related products
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
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