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RSS FeedPosted 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. ...
Posted by Michael Wonder on 02 Dec 2023
Orchard Therapeutics receives US FDA fast track designation for OTL-203 in MPS-IH
30 November 2023 - Previously reported results from ongoing proof of concept study showed extensive metabolic correction, continued cognitive, motor, and ...
Posted by Michael Wonder on 29 Nov 2023
FDA investigating serious risk of T-cell malignancy following BCMA directed or CD19 directed autologous chimeric antigen receptor (CAR) T cell immunotherapies
28 November 2023 - The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR positive lymphoma, in ...
Posted by Michael Wonder on 28 Nov 2023
Sernova receives orphan drug and rare paediatric disease designations for its haemophilia A program from FDA
27 November 2023 - Sernova today announced the US FDA has granted both orphan drug designation and rare paediatric disease designation ...
Posted by Michael Wonder on 28 Nov 2023
Autolus Therapeutics submits biologics license application to US FDA for obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
27 November 2023 - BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory adult B-cell acute ...
Posted by Michael Wonder on 28 Nov 2023
Genelux Corporation receives FDA fast track designation for olvi-vec in platinum resistant/refractory ovarian cancer
27 November 2023 - Pivotal Phase 3 study of olvi-vec in platinum resistant/refractory ovarian cancer initiated in September 2022. ...
Posted by Michael Wonder on 20 Nov 2023
Bristol Myers Squibb and 2seventy bio provide update on US FDA review of sBLA for Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple-class exposed relapsed or refractory multiple myeloma
20 November 2023 - Bristol Myers Squibb and 2seventy bio today announced the US FDA Oncologic Drugs Advisory Committee will ...
Posted by Michael Wonder on 20 Nov 2023
The FDA is at a crossroads on cell and gene therapies
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...