USFDA declines to approve Viatris-Mapi Pharma's monthly multiple sclerosis injection
The companies were seeking the FDA's nod for GA Depot, a long-acting version of glatiramer acetate, which is approved for relapsing forms of MS.
The U.S. FDA has declined to approve Viatris and Mapi Pharma's once-a-month injection for treating relapsing forms of debilitating neurological condition multiple sclerosis (MS), the companies said.The companies were reviewing the content of the health regulator's so called complete response letter (CRL) and would soon determine the appropriate next steps, they said, without disclosing...
The U.S. FDA has declined to approve Viatris and Mapi Pharma's once-a-month injection for treating relapsing forms of debilitating neurological condition multiple sclerosis (MS), the companies said.
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Original news source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-declines-approve-viatriss-injection-multiple-sclerosis-2024-03-11/#:~:text=March 11 (Reuters) - The,the companies said on Monday.
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