1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients ...
18 March 2021 - Celularity announced that the company has received fast track designation from the U.S. FDA for its non-genetically ...
5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
5 February 2021 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for the treatment of adult patients with ...
11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
2 December 2020 - Mesoblast today announced that the United States FDA has granted fast track designation for remestemcel-L in the ...
16 November 2020 - Bristol-Myers Squibb today announced that the U.S. FDA has informed the company that its review of ...
1 October 2020 - Phase 1 clinical trial is now enrolling patients with blood cancers. ...
2 October 2020 - Mesoblast announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter ...
9 September 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to PBCAR269A for the treatment ...