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RSS FeedPosted by Michael Wonder on 06 Dec 2024
FDA grants breakthrough therapy designation to sacituzumab tirumotecan for the treatment of certain patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations
3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US. ...
Posted by Michael Wonder on 19 Nov 2024
FDA grants breakthrough therapy designation to Huahui Health's libevitug (HH-003) for treatment of chronic hepatitis D virus infection
18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an ...
Posted by Michael Wonder on 12 Nov 2024
Nipocalimab is the first and only investigational therapy granted US FDA breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease
11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved ...
Posted by Michael Wonder on 10 Oct 2024
Volixibat granted breakthrough therapy designation for cholestatic pruritus in primary biliary cholangitis
10 October 2024 - Designation based on positive interim analysis of Phase 2b VANTAGE study. ...
Posted by Michael Wonder on 09 Oct 2024
Biogen receives US FDA breakthrough therapy designation for felzartamab for the treatment of antibody mediated rejection in kidney transplant recipients
9 October 2024 - Designation is based on data from the clinical development program which demonstrated clinical proof of concept. ...
Posted by Michael Wonder on 08 Oct 2024
Boehringer receives US FDA breakthrough therapy designation and initiates two Phase 3 trials in MASH for survodutide
8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis ...
Posted by Michael Wonder on 07 Oct 2024
Ultragenyx receives breakthrough therapy designation for setrusumab (UX143) in osteogenesis imperfecta
7 October 2024 - Ultragenyx today announced that it has received breakthrough therapy designation from the US FDA for setrusumab (UX143) ...
Posted by Michael Wonder on 17 Sep 2024
BridgeBio announces infigratinib is the first ever investigational therapeutic option for achondroplasia to be awarded breakthrough therapy designation by the FDA
17 September 2024 - Breakthrough therapy designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting ...
Posted by Michael Wonder on 11 Sep 2024
Neuraptive Therapeutics receives FDA breakthrough therapy designation for NTX-001
11 September 2024 - Neuraptive Therapeutics today announced that NTX-001 has been granted breakthrough therapy designation, thus providing the potential for ...
Posted by Michael Wonder on 10 Sep 2024
Arrowhead Pharmaceuticals receives FDA breakthrough therapy designation for plozasiran
10 September 2024 - PALISADE Phase 3 results demonstrate plozasiran reduced triglycerides by 80% from baseline and reduced the risk of ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapies approved based on surrogate endpoints often lack post-marketing requirements
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
Posted by Michael Wonder on 20 Aug 2024
GSK receives US FDA breakthrough therapy designation for its B7-H3 targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer
20 August 2024 - Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type. ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu granted breakthrough therapy designation in US for certain patients with HER2 low or HER2 ultralow metastatic breast cancer
19 August 2024 - Daiichi Sankyo and AstraZeneca's Enhertu has now been granted eight breakthrough therapy designations with latest based ...
Posted by Michael Wonder on 15 Aug 2024
Imfinzi granted priority review and breakthrough therapy designation for patients with limited-stage small cell lung cancer in the US
15 August 2024 - Based on ADRIATIC Phase 3 trial which demonstrated statistically significant and clinically meaningful overall survival and ...
Posted by Michael Wonder on 06 Aug 2024
Attralus receives breakthrough therapy designation for its pan-amyloid diagnostic PET imaging candidate 124I-evuzamitide (AT-01) for cardiac amyloidosis
5 August 2024 - A Phase 3 study for 124I-evuzamitide in patients with suspected cardiac amyloidosis is anticipated to begin ...