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Ascendis Pharma A/S

http://www.ascendispharma.com/

Latest From Ascendis Pharma A/S

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

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

US FDA May User Fee Preview: Vaccines, Gene Therapy, And Double Oncologics

Five novel agents are among the user fee goal dates coming up in May 2024.

US FDA Performance Tracker Review Pathway

AstraZeneca Spends $800m On Amolyt And Awaits A Readout

The Phase III trial of hypoparathyroidism asset eneboparatide will have to hit if AstraZeneca is going to carve out market share from Ascendis.

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