9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK ...
9 January 2024 - Sellas Life Sciences Group today announced that the US FDA has granted fast track designation to SLS009 ...
8 January 2024 - Astellas Pharma today announced the US FDA issued a complete response letter on 4 January 2024, ...
5 January 2023 - ProfoundBio today announced that the US FDA has granted fast track designation for rinatabart sesutecan (Rina-S; ...
19 December 2023 - Imaging Biometrics is pleased to announce that the US FDA has granted fast track designation for oral ...
27 December 2023 - Shanghai Henlius Biotech announced that the US FDA granted fast track designation for HLX42, an investigational EGFR ...
22 December 2023 - Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients ...
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
21 December 2023 - Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful ...
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
15 December 2023 - Today, the FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for ...
14 December 2023 - Today, the FDA approved belzutifan (Welireg, Merck) for patients with advanced renal cell carcinoma following a ...
13 December 2023 - Abbisko Therapeutics today announced that its CSF-1R inhibitor pimicotinib (ABSK021) has been granted the fast track designation ...
13 December 2023 - FDA target action date is 12 June 2024. ...
13 December 2023 - Today, the FDA approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and paediatric ...