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Latest From Insmed Incorporated

US FDA Clarifies Populations And Anti-Infective Indications Eligible For Approval Under LPAD

Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.

Guidance Documents Review Pathway

Antifungal Drug Sponsors Seek Clearer Regulatory Pathway, Less Burdensome Trials

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

Clinical Trials Rare Diseases

Keeping Track: The Breakthrough Designations Of Summer Eschew Phase I

The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Review Pathway

EMA Says Yes To GSK’s Belantamab But Rejects Tagraxofusp & Emapalumab

GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.

Europe Approvals
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