Janssen receives positive CHMP opinion for Carvykti (ciltacabtagene autoleucel) for treatment in earlier lines of relapsed and refractory multiple myeloma

23 February 2024 - Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the ...

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Terminally ill patients despair amid price war over CAR-T cancer therapy

22 February 2024 - Australia risks “being pushed to the back of the queue” of countries to gain access to ...

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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 ...

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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. ...

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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 ...

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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. ...

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Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma

26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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