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RSS FeedPosted by Michael Wonder on 08 Apr 2024
Carvykti is the first and only BCMA targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
Posted by Michael Wonder on 05 Apr 2024
US FDA approves Bristol Myers Squibb and 2seventy bio’s Abecma for triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy
5 April 2024 - Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% ...
Posted by Michael Wonder on 19 Mar 2024
Deverra Therapeutics granted FDA regenerative medicine advanced therapy and orphan drug designations for DVX101 (Dilanubicel) for the treatment of acute myeloid leukaemia
19 March 2024 - Deverra Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to its lead ...
Posted by Michael Wonder on 15 Mar 2024
US FDA approves Bristol Myers Squibb’s Breyanzi as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
14 March 2024 - In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in ...
Posted by Michael Wonder on 29 Feb 2024
Indapta Therapeutics receives US FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma
29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...
Posted by Michael Wonder on 16 Feb 2024
FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
Posted by Michael Wonder on 10 Feb 2024
Human acellular vessel biologics license application granted priority review by US FDA for the treatment of vascular trauma
9 February 2024 - PDUFA date set for 10 August 2024. ...
Posted by Michael Wonder on 01 Feb 2024
Adaptimmune announces US FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review
31 January 2024 - Adaptimmune Therapeutics today announced that the US FDA has accepted for priority review its biologics license application ...
Posted by Michael Wonder on 30 Jan 2024
Regulatory applications accepted in the US and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma
30 January 2024 - US FDA grants both follicular lymphoma and mantle cell lymphoma applications priority review. ...
Posted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 23 Jan 2024
Autolus Therapeutics announces acceptance of biologics license application for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukaemia
22 January 2024 - PDUFA goal date is 16 November 2024. ...
Posted by Michael Wonder on 19 Jan 2024
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory progressive multiple sclerosis
19 January 2024 - The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-7 Phase 2 ...
Posted by Michael Wonder on 19 Jan 2024
US FDA grants mesoblast rare paediatric disease designation for Revascor (Rexlemestrocel-L) in children with congenital heart disease
19 January 2024 - Revascor increases size of left heart chamber and improves surgical outcomes in children with hypoplastic left ...
Posted by Michael Wonder on 12 Dec 2023
Humacyte submits biologics license application to US FDA seeking approval of human acellular vessel for the treatment of vascular trauma
12 December 2023 - BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the human ...
Posted by Michael Wonder on 08 Dec 2023
Adaptimmune completes submission of rolling biologics license application to US FDA for afami-cel for the treatment of advanced synovial sarcoma
6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US FDA. ...