FDA grants breakthrough therapy designation for Roche's CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma

14 July 2020 - Tenth breakthrough therapy designation awarded for Roche's haematology medicines. ...

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Concert Pharmaceuticals receives FDA breakthrough therapy designation for CTP-543 for the treatment of alopecia areata

8 July 2020 - Designation based on Phase 2 data demonstrating significant hair regrowth in patients with alopecia areata. ...

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EspeRare receives FDA breakthrough therapy designation for investigational prenatal treatment ER-004 in X-linked hypohidrotic ectodermal dysplasia

6 July 2020 - EspeRare today announced that the U.S. FDA has granted breakthrough therapy designation to investigational ER-004 protein ...

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Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-05 for the treatment of Alzheimer’s disease agitation

26 June 2020 - Axsome now granted two breakthrough therapy designations for AXS-05 for separate CNS indications. ...

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Insmed receives FDA breakthrough therapy designation for brensocatib in patients with non-cystic fibrosis bronchiectasis

 8 June 2020 - Full results from phase 2 WILLOW study of brensocatib in non-cystic fibrosis bronchiectasis to be presented at ...

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AiCuris was granted breakthrough therapy designation by U.S. FDA for pritelivir for the treatment of HSV infections in immunocompromised patients

5 June 2020 - AiCuris is currently preparing to add a pivotal Phase 3 trial part to the ongoing Phase 2 ...

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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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