16 January 2024 - Fast track designation follows positive Phase 1 data presented at the American Society of Hematology that supports ...
12 January 2024 - RemeGen announced recently that its independently developed mesothelin targeting antibody drug conjugate RC88 has been granted fast ...
9 January 2024 - Shorla Oncology announced today that the US FDA has accepted for review the company’s new drug application ...
15 January 2024 - On 12 January 2024, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapy for patients with FIGO 2014 stage ...
10 January 2024 - Mirati Therapeutics today announced that the European Commission granted conditional marketing authorisation for Krazati (adagrasib) as ...
9 January 2024 - Submission based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK ...
8 January 2024 - Talzenna is the first and only PARP inhibitor approved in combination with standard of care Xtandi ...
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; ...
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity ...
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 ...