Blog
RSS FeedPosted by Michael Wonder on 23 Jan 2024
Ensysce Biosciences announces FDA breakthrough therapy designation granted for PF614-MPAR
23 January 2024 - FDA acknowledges significant potential impact of MPAR's oral overdose protection. ...
Posted by Michael Wonder on 22 Dec 2023
BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
Posted by Michael Wonder on 06 Dec 2023
Neurocrine Biosciences receives breakthrough therapy designation from US FDA for crinecerfont in congenital adrenal hyperplasia
5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...
Posted by Michael Wonder on 05 Dec 2023
CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high risk BCG unresponsive non-muscle invasive bladder cancer
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
Posted by Michael Wonder on 05 Dec 2023
Johnson & Johnson's investigational TAR-200 granted US FDA breakthrough therapy designation for the treatment of high risk non-muscle invasive bladder cancer
4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 17 Nov 2023
Palvella Therapeutics announces US FDA breakthrough therapy designation granted to Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of microcystic lymphatic malformations
16 November 2023 - Qtorin rapamycin has potential to be first approved therapy and standard of care in the US for ...
Posted by Michael Wonder on 02 Nov 2023
Nectero Medical granted breakthrough therapy designation for the Nectero EAST system to treat infrarenal AAA
1 November 2023 - Phase 2/3 clinical trial to initiate enrolment in Q4, 2023. ...
Posted by Michael Wonder on 31 Oct 2023
HI-Bio announces felzartamab granted breakthrough therapy designation by US Food and Drug Administration for primary membranous nephropathy
31 October 2023 - Human Immunology Biosciences today announced that the US FDA has granted breakthrough therapy designation for felzartamab in ...
Posted by Michael Wonder on 30 Oct 2023
ArriVent receives FDA breakthrough therapy designation for furmonertinib for first-line treatment of advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
30 October 2023 - ArriVent Biopharma today announced that the US FDA has granted breakthrough therapy designation for furmonertinib for ...
Posted by Michael Wonder on 26 Oct 2023
US FDA grants Paige breakthrough device designation for cancer detection in breast lymph nodes
26 October 2023 - Paige announced today that the US FDA has granted breakthrough device designation for Paige Lymph Node, an ...
Posted by Michael Wonder on 24 Oct 2023
Bristol Myers Squibb announces US FDA breakthrough therapy designation for investigational LPA1 antagonist for progressive pulmonary fibrosis
24 October 2023 - Designation is based on results from the progressive pulmonary fibrosis cohort of the Phase 2 study ...
Posted by Michael Wonder on 23 Oct 2023
Seladelpar granted revised breakthrough therapy designation for the treatment of primary biliary cholangitis including pruritus in patients without cirrhosis or with compensated cirrhosis
23 October 2023 - CymaBay Therapeutics today announced that the US FDA has revised the originally granted breakthrough therapy designation for ...
Posted by Michael Wonder on 19 Oct 2023
FDA Grants SeaStar Medical’s selective cytopheretic device breakthrough device designation for hepatorenal syndrome
18 October 2023 - SeaStar Medical announces receipt of US FDA breakthrough device designation for its patented, first in class, ...