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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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) ...

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