Baudax Bio announces PDUFA date for intravenous meloxicam

22 January 2020 - Baudax Bio today announced that the U.S. FDA has set a PDUFA goal date of 20 ...

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Jazz Pharmaceuticals submits new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy

22 January 2020 - Jazz Pharmaceuticals today announced the submission of a new drug application to the U.S. Food and Drug ...

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Supernus announces FDA acceptance for review of new drug application for SPN-812 for the treatment of ADHD

21 January 2020 - PN-812 (viloxazine hydrochloride), a once-daily novel serotonin norepinephrine modulating agent, demonstrates a reduction in ADHD-RS-5 total score ...

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FDA accepts Evoke Pharma’s NDA resubmission for Gimoti

21 January 2020 - PDUFA Target Goal Date is 19 June 2020. ...

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Janssen seeks expanded use of Imbruvica (ibrutinib) in combination with rituximab for patients with previously untreated chronic lymphocytic leukaemia

20 January 2020 - Application supported by the Phase 3 E1912 study evaluating the use of ibrutinib in combination with rituximab, ...

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FDA delays decision on Intercept's NASH drug by three months

20 January 2020 - Action date pushed back to 26 June. ...

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TG Therapeutics initiates rolling submission of new drug application to U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma

16 January 2020 - Completion of rolling submission for the MZL/FL NDA expected in 1H20. ...

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Nektar issues statement regarding FDA Advisory Committee vote for oxycodegol

15 January 2020 - Nektar Therapeutics issued a statement today following a meeting of the FDA's Anesthetic and Analgesic Drug ...

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Janssen seeks expanded use of Spravato (esketamine) nasal spray in Europe as a treatment for depressive symptoms in adults with major depressive disorder who have current suicidal ideation with intent

15 January 2020 - In two pivotal Phase 3 trials, Spravato combined with comprehensive standard of care achieved statistically significant ...

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Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer

15 January 2020 - FDA has assigned PDUFA date of 15 May 2020. ...

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U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line non-small cell lung cancer

15 January 2020 - Application based on results from Part 1 of Phase 3 CheckMate-227 study. ...

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Chiasma announces FDA acceptance of Mycapssa new drug application resubmission

13 January 2020 - FDA sets PDUFA date of 26 June 2020. ...

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Ultragenyx and Kyowa Kirin announce submission of supplemental biologics license application to U.S. FDA for Crysvita (burosumab) for tumour-induced osteomalacia

13 January 2020 - Ultragenyx and Kyowa Kirin today announced that they submitted a supplemental biologics license application to the U.S. ...

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Lynparza regulatory submission granted priority review in the US for first-line maintenance treatment with bevacizumab in advanced ovarian cancer

13 January 2020 - Submission based on Phase III PAOLA-1 trial for patients with advanced ovarian cancer regardless of biomarker ...

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Acerus provides update on Natesto approval process in Europe

10 January 2020 - Acerus Pharmaceuticals today announced that the dossier filed as a decentralised Procedure in 19 European countries ...

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