FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis

18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis. ...

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When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates

11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...

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Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations

11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...

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Ridgeback Biotherapeutics announces receipt of breakthrough therapy designation from FDA for mAb114

6 September 2019 - Ridgeback Biotherapeutics today announced that the FDA has recently granted mAb114, an experimental treatment for Ebola, ...

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Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer

6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019. ...

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Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults

3 September 2019 - Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's investigational ...

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SpringWorks Therapeutics receives breakthrough therapy designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumours

29 August 2019 - SpringWorks Therapeutics today announced the U.S. FDA has granted breakthrough therapy designation for nirogacestat, an oral, selective, ...

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Eiger announces FDA breakthrough therapy designation for peginterferon lambda for treatment of hepatitis delta virus infection

20 August 2019 - Fourth Eiger program granted breakthrough therapy designation. ...

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FDA grants breakthrough therapy designation for trilaciclib based on myelopreservation data in small cell lung cancer patients

8 August 2019 - G1 Therapeutics today provided a corporate and financial update for the second quarter ended 30 June 2019. ...

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Calquence granted US breakthrough therapy designation for chronic lymphocytic leukaemia

14 August 2019 - Designation based on positive results from two Phase III trials. ...

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Provention Bio announces breakthrough therapy designation for teplizumab for the prevention or delay of clinical type 1 diabetes in at-risk individuals

5 August 2019 - Provention Bio today announced that the U.S. FDA has granted breakthrough therapy designation to teplizumab (PRV-031) ...

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Nektar Therapeutics and Bristol-Myers Squibb announce U.S. FDA breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Opdivo (nivolumab) for the treatment of patients with untreated advanced melanoma

1 August 2019 - Nektar Therapeutics and Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for ...

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Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)

31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...

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Breakthrough drugs raise worries over higher costs

25 July 2019 - Potential breakthroughs in medical treatment for serious diseases are turning what was once “the stuff of ...

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Aeglea BioTherapeutics receives FDA breakthrough therapy designation for pegzilarginase for treatment of arginase 1 deficiency

24 July 2019 - Designation follows recently reported ARG1-D Phase 1/2 data demonstrating clinical response in patients rreated with pegzilarginase. ...

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