Enhertu granted breakthrough therapy designation in the U.S. for HER2 mutant metastatic non-small cell lung cancer

18 May 2020 - Designation based on phase 2 DESTINY-Lung01. ...

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Enhertu granted breakthrough therapy designation in the U.S. for HER2 positive metastatic gastric cancer

11 May 2020 - Designation based on data from pivotal phase 2 DESTINY-Gastric01 trial. ...

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Takeda announces U.S. FDA breakthrough therapy designation for mobocertinib (TAK-788) for the treatment of NSCLC patients with EGFR exon 20 insertion mutations

27 April 2020 - Designation represents positive progress for a unique patient population in need of targeted therapy options. ...

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Merck and Pfizer receive US FDA breakthrough therapy designation and submit application for Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma

9 April 2020 - Breakthrough therapy designation and submission based on positive Phase III JAVELIN Bladder 100 study results. ...

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Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension

8 April 2020 - Sotatercept granted first FDA breakthrough therapy designation in pulmonary arterial hypertension since the Agency established the designation ...

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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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