Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 01 Aug 2024
Achieve Life Sciences announces FDA grants breakthrough therapy designation to cytisinicline for the treatment of e-cigarette or vaping nicotine dependence
31 July 2024 - Achieve Life Sciences announced today that the US FDA has granted breakthrough therapy designation for cytisinicline for ...
Posted by Michael Wonder on 16 Jul 2024
AusperBio receives breakthrough therapy designation for AHB-137 in chronic hepatitis B treatment
10 July 2024 - AHB-137 gains breakthrough therapy designation from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety ...
Posted by Michael Wonder on 02 Jul 2024
FDA breakthrough therapy designation reduced late-stage drug development time
1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies ...
Posted by Michael Wonder on 02 Jul 2024
Longboard Pharmaceuticals receives breakthrough therapy designation for bexicaserin
1 July 2024 - Longboard Pharmaceuticals today announced that the FDA has granted breakthrough therapy designation for its investigational drug ...
Posted by Michael Wonder on 28 May 2024
Vera Therapeutics receives US FDA breakthrough therapy designation for atacicept in immunoglobulin A nephropathy
28 May 2024 - Vera Therapeutics today announced that the US FDA has granted breakthrough therapy designation to atacicept for the ...
Posted by Michael Wonder on 22 May 2024
Roche granted FDA breakthrough device designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk
22 May 2024 - The test has been developed in collaboration with Amgen. ...
Posted by Michael Wonder on 22 May 2024
FDA grants breakthrough therapy designation to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
21 May 2024 - The designation is based on Phase 3 INAVO120 results, showing the inavolisib based regimen more than doubled ...
Posted by Michael Wonder on 22 May 2024
Durect Corporation receives FDA breakthrough therapy designation for larsucosterol in alcohol-associated hepatitis
21 May 2024 - Durect plans to confirm the efficacy and safety of larsucosterol in a registrational Phase 3 clinical ...
Posted by Michael Wonder on 16 May 2024
Nuvalent receives US FDA breakthrough therapy designation for NVL-655
16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the ...
Posted by Michael Wonder on 13 May 2024
Petosemtamab granted breakthrough therapy designation by the US FDA
13 May 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for petosemtamab for the ...