NDA and BLA submission news from our US FDA Performance Tracker.
Two novel oncologics joined the September user fee calendar at the US FDA this week: an antibody-immunotoxin conjugate from AstraZeneca PLC for a rare, slow-growing leukemia and an epidermal growth factor receptor (EGFR)-directed therapy from Pfizer Inc. Both are receiving priority review.
Promius Pharma LLC and Sunovion Pharmaceuticals Inc., taking the 505(b)(2) NDA pathway, submitted applications for a sumatriptan nasal...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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