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RSS FeedPosted by Michael Wonder on 02 Dec 2025
Solid Biosciences receives FDA rare paediatric disease designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
1 December 2025 - Solid Biosciences today announced that it received rare paediatric disease designation from the US FDA for SGT-212, ...
Posted by Michael Wonder on 27 Nov 2025
US FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma
26 November 2025 - BeOne Medicines today announced that the US FDA has accepted and granted priority review to a ...
Posted by Michael Wonder on 26 Nov 2025
Novo Nordisk files for FDA approval of a higher dose of Wegovy injection 7.2 mg
26 November 2025 - Today, Novo Nordisk announced the submission of an supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 08 Nov 2025
FDA awards second batch of national priority vouchers
6 November 2025 - The US FDA today announced six additional awardees under the Commissioner’s National Priority Voucher pilot program. ...
Posted by Michael Wonder on 08 Nov 2025
Boehringer awarded FDA Commissioner's National Priority Voucher for Hernexeos in HER2 lung cancer
7 November 2025 - The US FDA has awarded a Commissioner's National Priority Voucher for Hernexeos (zongertinib tablets), currently under investigation ...
Posted by Michael Wonder on 28 Oct 2025
Cellectar Biosciences receives rare paediatric disease designation from US FDA for iopofosine I 131 in relapsed or refractory paediatric high-grade glioma
27 October 2025 - Cellectar Biosciences today announced the US FDA has granted rare paediatric drug designation for iopofosine I ...
Posted by Michael Wonder on 27 Oct 2025
Flaws in the FDA’s new priority voucher program
25 October 2025 - A new FDA program is being promoted as a tool to facilitate the development and approval of ...
Posted by Michael Wonder on 25 Oct 2025
Revolution Medicines awarded voucher for daraxonrasib (RMC-6236) under FDA Commissioner's National Priority Voucher Pilot Program
16 October 2025 - Revolution Medicines today announced that the US FDA has granted a non-transferrable voucher for daraxonrasib (RMC-6236), ...
Posted by Michael Wonder on 24 Oct 2025
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for certain patients with muscle-invasive bladder cancer
23 October 2025 - Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the ...
Posted by Michael Wonder on 23 Oct 2025
Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer
21 October 2025 - Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced ...
Posted by Michael Wonder on 22 Oct 2025
Sanofi’s Tzield accepted for expedited review in the US for stage 3 type 1 diabetes through FDA Commissioner's National Priority Voucher pilot program
20 October 2025 - The US FDA has accepted for expedited review the supplemental biologics license application for Tzield (teplizumab-mzwv) to ...
Posted by Michael Wonder on 21 Oct 2025
FDA awards first ever national priority vouchers to nine sponsors
16 October 2025 - The US FDA today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot ...
Posted by Michael Wonder on 11 Oct 2025
FDA frants RMAT designation to Avobis Bio's implantable cell therapy AVB-114 for Crohn's perianal fistulas
3 October 2025 - Avobis Bio announced today that the US FDA has granted regenerative medicine advanced therapy designation for AVB-114, ...
Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...
Posted by Michael Wonder on 02 Oct 2025
Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years
1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for ...