2 October 2023 - Regulatory designation includes platinum-resistant, high grade serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube. ...
26 September 2023 - Abeona Therapeutics today announced the Company has submitted a biologics license application to the US FDA seeking ...
3 August 2023 - Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher incidence than previously ...
31 July 2023 - Invectys is pleased to announce the US FDA has granted fast track designation to its revolutionary ...
12 July 2023 - On July 6, 2023, Biosyngen received an official notification from the US FDA granting fast track ...
10 July 2023 - The US FDA granted a rare paediatric Disease designation to MyoPax.. ...
6 July 2023 - Marks third rare paediatric drug designation granted by FDA for pipeline candidate. ...
28 June 2023 - Today, the US FDA approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased ...
20 June 2023 - Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete ...
6 June 2023 - The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint ...
1 June 2023 - KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor T-cell therapy designed to deplete B cells, ...
26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...
15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...
4 May 2023 - HAV granted second RMAT designation by the FDA. ...
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...