16 May 2024 - Today, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, ...
17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...
16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the ...
16 May 2024 - Today, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive stage small cell lung ...
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
13 May 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for petosemtamab for the ...
9 May 2024 - SN Bioscience announced on 7 May that the FDA has granted fast track designation for small cell ...
10 May 2024 - Breakthrough therapy designation was granted based on positive data from the Phase 3 ASC4FIRST study, in which ...
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
6 May 2024 - If approved, zenocutuzumab will be the first targeted therapy for NRG1 positive cancer. ...
6 May 2024 - Application based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab ...
29 April 2024 - Today, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen) for recurrent or metastatic cervical ...
25 April 2024 - Compass Therapeutics today announced that the US FDA has granted fast track designation to CTX-009, the Company’s ...
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
24 April 2024 - Deverra Therapeutics today announced that the US FDA granted fast track designation to dilanubicel, the Company's ...