8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis ...
7 October 2024 - Ultragenyx today announced that it has received breakthrough therapy designation from the US FDA for setrusumab (UX143) ...
17 September 2024 - Breakthrough therapy designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting ...
11 September 2024 - Neuraptive Therapeutics today announced that NTX-001 has been granted breakthrough therapy designation, thus providing the potential for ...
10 September 2024 - PALISADE Phase 3 results demonstrate plozasiran reduced triglycerides by 80% from baseline and reduced the risk of ...
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
20 August 2024 - Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type. ...
19 August 2024 - Daiichi Sankyo and AstraZeneca's Enhertu has now been granted eight breakthrough therapy designations with latest based ...
15 August 2024 - Based on ADRIATIC Phase 3 trial which demonstrated statistically significant and clinically meaningful overall survival and ...
5 August 2024 - A Phase 3 study for 124I-evuzamitide in patients with suspected cardiac amyloidosis is anticipated to begin ...
31 July 2024 - Achieve Life Sciences announced today that the US FDA has granted breakthrough therapy designation for cytisinicline for ...
10 July 2024 - AHB-137 gains breakthrough therapy designation from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety ...
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
1 July 2024 - Longboard Pharmaceuticals today announced that the FDA has granted breakthrough therapy designation for its investigational drug ...
28 May 2024 - Vera Therapeutics today announced that the US FDA has granted breakthrough therapy designation to atacicept for the ...