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. ...
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...
27 October 2022 - AVR-RD-02 has previously received fast track status from FDA, orphan drug designation in the US and EU, ...
17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...
12 October 2022 - PDUFA target action date is 31 March 2023 ...
6 October 2022 - Approval is based on positive efficacy and safety results of the ILLUMINATE-C Phase 3 study of Oxlumo ...
29 September 2022 - BLA includes substantial body of data from pivotal Phase 3 and on-going Phase 1/2 studies. ...
20 September 2022 - AVR-RD-04 has previously received orphan drug designation from FDA and EMA. ...
16 September 2022 - Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys ...
15 September 2022 - Aro Biotherapeutics today announced that the US FDA granted rare paediatric drug designation for ABX1100, an investigational ...
8 September 2022 - Designation provides potential for expedited drug development path. ...