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Minerva Neurosciences, Inc.

http://www.minervaneurosciences.com/

Latest From Minerva Neurosciences, Inc.

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

Rare Diseases Drug Approval Standards

Marching On: Eight Novel Agents Among March Goal Dates For US FDA

Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

US FDA Performance Tracker Approvals

Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.

US States Approvals

Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

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  • Other Names / Subsidiaries
    • Cyrenaic Pharmaceuticals, Inc.
    • Mind-NRG SA
    • Sonkei Pharmaceuticals, Inc.
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