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RSS FeedPosted by Michael Wonder on 16 Mar 2020
Lilly receives FDA breakthrough therapy designation for baricitinib for the treatment of alopecia areata
16 March 2020 - Recognition reinforces baricitinib's potential to be the first FDA approved medicine for individuals living with alopecia areata. ...
Posted by Michael Wonder on 11 Mar 2020
Janssen announces U.S. FDA breakthrough therapy designation granted for JNJ-6372 for the treatment of non-small cell lung cancer
10 March 2020 - JNJ-6372, a dual-targeting EGFR-MET bispecific antibody, is being investigated for adults with non-small cell lung cancer EGFR ...
Posted by Michael Wonder on 03 Mar 2020
FDA grants breakthrough therapy designation for Genentech’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease
2 March 2020 - There are currently no FDA approved treatments for unclassifiable ILD, a debilitating, severe respiratory condition. ...
Posted by Michael Wonder on 29 Feb 2020
FDA grants breakthrough therapy designation for Debiopharm's novel chemo-radio sensititiser Debio 1143 for front-line treatment of head & neck cancer
27 February 2020 - The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination ...
Posted by Michael Wonder on 24 Feb 2020
ContraFect announces U.S. FDA grants breakthrough therapy designation to exebacase for the treatment of Methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia, including right-sided endocarditis
24 February 2020 -- ContraFect today announced that that the U.S. FDA has granted breakthrough therapy designation to exebacase for ...
Posted by Michael Wonder on 19 Feb 2020
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for Padcev (enfortumab vedotin-ejfv) in combination with pembrolizumab in first-line advanced bladder cancer
19 February 2020 - Breakthrough therapy designation based on initial results from Phase 1b/2 EV-103 clinical trial. ...
Posted by Michael Wonder on 04 Feb 2020
Resverlogix receives US FDA breakthrough therapy designation for apabetalone
3 February 2020 - Resverlogix is pleased to announce the U.S. FDA has granted breakthrough therapy designation for apabetalone in combination ...
Posted by Michael Wonder on 30 Jan 2020
Aprea Therapeutics receives FDA breakthrough therapy designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes with a TP53 mutation
30 January 2020 - Aprea Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for APR-246 in combination ...
Posted by Michael Wonder on 31 Dec 2019
Savara granted breakthrough therapy designation for Molgradex for the treatment of auto-immune pulmonary alveolar proteinosis
30 December 2019 - Savara today announced that the U.S. FDA has granted breakthrough therapy designation for Molgradex, an inhaled ...
Posted by Michael Wonder on 18 Dec 2019
Seattle Genetics announces U.S. FDA grants breakthrough therapy designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer
18 December 2019 - New drug application submission to U.S. FDA expected by first quarter of 2020. ...
Posted by Michael Wonder on 18 Dec 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation
16 December 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) for ...
Posted by Michael Wonder on 09 Dec 2019
Galderma investigational therapy nemolizumab granted FDA breakthrough therapy designation for the treatment of patients suffering from prurigo nodularis
9 December 2019 - Galderma today announced that the U.S. FDA has granted breakthrough therapy Designation to the investigational therapy ...
Posted by Michael Wonder on 07 Dec 2019
Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma
6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...
Posted by Michael Wonder on 04 Dec 2019
ImmunityBio granted FDA breakthrough therapy designation for N-803 IL-15 superagonist in non-muscle invasive bladder cancer
4 December 2019 - Results of Phase 1 and 2 studies in BCG unresponsive non-muscle invasive bladder cancer in high risk ...
Posted by Michael Wonder on 04 Dec 2019
Bristol-Myers Squibb announces U.S. FDA breakthrough therapy designation for Orencia (abatacept) to help prevent acute graft-versus-host disease, a potentially life-threatening complication after stem cell transplant
4 December 2019 - Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for Orencia (abatacept) ...