The latest drug development news and highlights from our US FDA Performance Tracker.
The US FDA's Center for Drug Evaluation and Research (CDER) topped off its torrid August with an approval for Merck & Co. Inc.'s non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine, bringing the US FDA's novel drug approval count for the year to 34.
Slowing the growth of the total, however, was the issuance of complete response letters (CRLs) for Sunovion Pharmaceuticals Inc.'s...
<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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