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RSS FeedPosted by Michael Wonder on 23 Jan 2020
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 ...
Posted by Michael Wonder on 23 Jan 2020
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 ...
Posted by Michael Wonder on 22 Jan 2020
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 ...
Posted by Michael Wonder on 22 Jan 2020
FDA accepts Evoke Pharma’s NDA resubmission for Gimoti
21 January 2020 - PDUFA Target Goal Date is 19 June 2020. ...
Posted by Michael Wonder on 21 Jan 2020
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, ...
Posted by Michael Wonder on 20 Jan 2020
FDA delays decision on Intercept's NASH drug by three months
20 January 2020 - Action date pushed back to 26 June. ...
Posted by Michael Wonder on 16 Jan 2020
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. ...
Posted by Michael Wonder on 16 Jan 2020
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 ...
Posted by Michael Wonder on 16 Jan 2020
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 ...
Posted by Michael Wonder on 15 Jan 2020
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. ...
Posted by Michael Wonder on 15 Jan 2020
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. ...
Posted by Michael Wonder on 14 Jan 2020
Chiasma announces FDA acceptance of Mycapssa new drug application resubmission
13 January 2020 - FDA sets PDUFA date of 26 June 2020. ...
Posted by Michael Wonder on 14 Jan 2020
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. ...
Posted by Michael Wonder on 13 Jan 2020
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 ...
Posted by Michael Wonder on 12 Jan 2020
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 ...