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 ...
23 April 2024 - Roche Canada will be working closely with the pan-Canadian Pharmaceutical Alliance, as well as federal, provincial, ...
23 April 2024 - Today, the FDA granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals) for patients 6 months ...
23 April 2024 - Approval is based on results from the positive Phase 3 EMBARK study which showed Xtandi alone ...
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
22 April 2024 - Ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for NPM1 mutant AML. ...
22 April 2024 - Today, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult ...
22 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with ciltacabtagene autoleucel ...
19 April 2024 - Approval is based on the Phase 3 KEYNOTE-859 trial. ...
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
18 April 2024 - Approval based on Phase 3 ALINA study showing Alecensa reduced the risk of disease recurrence or death ...
16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...