BioNumerik Pharmaceuticals, Inc.
https://bionumerik.com/
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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.
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.
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.
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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