Genentech/AbbVie drug becomes the seventh product known to be pilot-testing US FDA's new pathway; our infographic details the program's goals and how it has been used so far for more efficient reviews of supplemental oncology indications.
Genentech Inc. is at the forefront of sponsors vying to use the US FDA Oncology Center of Excellence’s Real-Time Oncology Review (RTOR) pilot program, as the Roche subsidiary announced a second application being reviewed under the speedy new pathway.
A supplemental new drug application (sNDA) for a new indication for Venclexta (venetoclax) – use in combination with Gazyva (obinutuzumab)...
<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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