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RSS FeedPosted 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 12 Dec 2023
Orchard Therapeutics receives Swissmedic approval for Libmeldy in early-onset MLD
11 December 2023 - Orchard Therapeutics today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy (atidarsagene autotemcel), a ...
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 07 Dec 2023
Bristol Myers Squibb's Abecma becomes first CAR T approved for use in earlier lines of therapy for patients with relapsed or refractory multiple myeloma in Japan
6 December 2023 - BMS announced today that the company has received manufacturing and marketing approval of the supplemental new ...
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 30 Nov 2023
Idecabtagene vicleucel for the treatment of patients with relapsed and refractory multiple myeloma after 3 or more treatments
30 November 2023 - NICE is unable to make a recommendation on the use of idecabtagene vicleucel (Abecma) for the treatment ...
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 29 Nov 2023
Tisagenlecleucel for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies
29 November 2023 - NICE is unable to make a recommendation on the use of tisagenlecleucel (Kymriah) for the treatment of ...
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 21 Nov 2023
Funding verdict looms on ‘future of cancer therapy’
21 November 2023 - The chance of survival for hundreds of Australians living with a deadly type of blood cancer ...
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 ...
Posted by Michael Wonder on 09 Nov 2023
CASI Pharmaceuticals announces market approval of CNCT19 by China NMPA
8 November 2023 - CASI Pharmaceuticals is thrilled to announce a major milestone in its partnership with Juventas Cell Therapy. ...