Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations

21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...

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Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation

19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...

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Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application

18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection ...

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GW Pharmaceuticals announces the sale of priority review voucher for $105 million

18 March 2019 - GW Pharmaceuticals today announced that GW Research Ltd. has entered into a definitive agreement to sell its ...

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FDA to undertake priority review of Dupixent (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps

8 March 2019 - The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as ...

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FDA grants rare paediatric disease designation to odiparcil for the treatment of MPS VI

5 March 2019 - Inventiva eligible to receive priority review voucher upon approval of odiparcil for the treatment of MPS VI. ...

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U.S. FDA grants priority review for fedratinib new drug application in myelofibrosis

5 March 2019 - U.S. FDA sets Prescription Drug User Fee Act action date for 3 September 2019. ...

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Lilly receives FDA priority review designation for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults

5 March 2019 - Eli Lilly and Company announced today that the U.S. FDA has granted priority review for its ...

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Celgene Corporation announces key regulatory update for Revlimid in lymphoma

26 February 2019 - U.S. FDA grants priority review for Revlimid (lenalidomide) in combination with rituximab for previously treated follicular and ...

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Spero Therapeutics receives QIDP designation from the U.S. FDA for the development of SPR720

26 February 2019 - Phase 1 top-line data readout for oral SPR720 expected in second half of 2019. ...

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FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder

22 February 2019 - FDA sets action date of 28 June 2019. ...

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Agios announces FDA acceptance of supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an IDH1 mutation not eligible for standard therapy

20 February 2019 - PDUFA date set for June 21 2019. ...

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FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) monotherapy for third-line treatment of patients with advanced small cell lung cancer

20 February 2019 - Marks first application for Keytruda in SCLC. ...

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FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma

19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease. ...

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FDA grants priority review to Roche’s personalised medicine entrectinib

19 February 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug ...

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