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BioNumerik Pharmaceuticals, Inc.

https://bionumerik.com/

Latest From BioNumerik Pharmaceuticals, Inc.

Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

US FDA Performance Tracker Approvals

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

New Oncologics Overwhelmingly Approved In US Before EU

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Regional Comparisons Approvals

Asia Deal Watch: ProGen To Partner With Rani On GLP-2 Agonist In Obesity

Plus deals involving Healios/Astellas Institute for Regenerative Medicine, Otsuka/Ionis, IMBiologics/Navigator and more.

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    • KI Pharmaceuticals, Inc.
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