16 May 2024 - Axogen is pleased to announce that it has initiated the rolling submission process with the US FDA ...
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
5 April 2024 - Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% ...
19 March 2024 - Deverra Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to its lead ...
14 March 2024 - In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in ...
29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
9 February 2024 - PDUFA date set for 10 August 2024. ...
31 January 2024 - Adaptimmune Therapeutics today announced that the US FDA has accepted for priority review its biologics license application ...
30 January 2024 - US FDA grants both follicular lymphoma and mantle cell lymphoma applications priority review. ...
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
22 January 2024 - PDUFA goal date is 16 November 2024. ...
19 January 2024 - The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-7 Phase 2 ...