29 March 2022 - Priority review granted by U.S. FDA. ...
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...
14 December 2021 - Findings from the ILLUMINATE-C Phase 3 study showed substantial reductions in plasma oxalate in PH1 patients with ...
8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in ...
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy ...
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...