12 December 2023 - Today, the US FDA announced it is creating a new advisory committee related to potential treatments for ...
8 December 2023 - As we’ve seen throughout our history, when the US Government invests in innovation, we can achieve breakthroughs ...
8 December 2023 - Today, the US FDA approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies ...
7 December 2023 - Next generation gene transfer therapy to treat Duchenne receives FDA fast track Designation. ...
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
27 November 2023 - PDUFA target action date is 25 May 2024. ...
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...
14 November 2023 - ATSN-101 has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious ...
6 November 2023 - AVB-101 is an investigational gene therapy delivered as a one time infusion directly to the brain, enabling ...
31 October 2023 - HG204 is the world first CRISPR RNA-editing therapy for the treatment of MECP2 duplication syndrome granted ...
26 October 2023 - CSL's Hemgenix is a one time, single dose treatment for adults with haemophilia B who require ...
13 October 2023 - Intellia Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to NTLA-2002 for ...
9 October 2023 - FDA cites insufficient evidence of clinical meaningfulness. ...
2 October 2023 - Novo Nordisk announced today that the US FDA has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, ...
2 October 2023 - PDUFA target action date is 31 March 2024. ...