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Oncopeptides AB

http://www.oncopeptides.se/

Latest From Oncopeptides AB

‘Dangling’ Accelerated Approval Reviews Expand At US FDA

The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.

Advisory Committees Cancer

US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.

Drug Review Advisory Committees

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Approvals Review Pathway

Pepaxto’s Accelerated Approval In Myeloma May Sink On OCEAN Trial's Adverse Survival Data

US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.

Review Pathway Clinical Trials
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