20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...
21 February 2023 - PDUFA date set for 8 October 2023. ...
14 February 2023 - More than 1,000 cell and gene therapy clinical trials registered. ...
13 February 2023 - A top official from the US FDA said he wants to see something similar to the agency’s ...
7 February 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
30 January 2023 - Nanoscope Therapeutics today announced that the US FDA has granted fast track designation to MCO-010, an ...
16 December 2022 - Today, the US FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector based gene therapy indicated for ...
1 December 2022 - When blood products giant CSL announced last week it had been given US regulatory approval for ...
28 November 2022 - Regulatory action date of 29 May 2023. ...
23 November 2022 - FDA no longer plans to hold an advisory committee meeting, as previously planned, to discuss the biologics ...
23 November 2022 - Australian biotech giant CSL will bring the first gene therapy for haemophilia B to market in ...
22 November 2022 - Today, the US FDA approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment ...
7 November 2022 - FDA requests submission of upcoming 3 year data analysis from Phase 3 GENEr8-1 trial. ...
7 November 2022 - OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency. ...