1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
25 April 2023 - Regulatory submission based on pivotal data from Part 1 of the RUBY Phase 3 trial. ...
20 April 2023 - Phase 3 data supporting the approval show treatment with Opzelura resulted in improved facial and total body ...
20 April 2023 - GenSight Biologics today announces that the Committee for Advanced Therapies (CAT) of the CHMP of the EMA ...
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
5 April 2023 - Application based on statistically significant and clinically meaningful improvements in serum bile acids, pruritus, bilirubin, and growth ...
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
22 February 2023 - Submissions based on favourable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma. ...
22 February 2023 - Approvals based on significant survival benefits in HIMALAYA and POSEIDON Phase 3 trials. ...
21 February 2023 - US FDA has set an action date for August 2023. ...
16 February 2023 - EMA marketing authorisation application for leniolisib changed to standard review timetable. ...
13 February 2023 - Camurus announced today that it has notified the EMA of its decision to withdraw the Type ...
9 February 2023 - EMA opinion on AVT04 could come as soon as the second half of 2023. ...