Original new drugs and biologics approved by US FDA.
Below are FDA's original approvals of NDAs and BLAs issued in the past week. Please see key below chart for a guide to frequently used abbreviations.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.
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.
Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
