28 September 2023 - Application based on clinically meaningful results from the Phase 3 STELLAR trial. ...
29 June 2023 - Roctavian's approval was based on durability, efficacy and safety results from the largest and longest Phase 3 ...
23 June 2023 - Ultravist-300, -370 is now the only contrast agent in the US indicated to visualise known or suspected ...
20 June 2023 - Pilot geared toward sponsors of certain oncology drug products used with certainin vitro diagnostic tests ...
6 June 2023 - The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint ...
16 December 2022 - Today, the US FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector based gene therapy indicated for ...
15 September 2022 - OpSens today announced that it has received 510(k) regulatory clearance from the US FDA for the SavvyWire, ...
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the ...
4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
9 March 2021 - The Ventana ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted ...
21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...
19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed. ...
12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...