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RSS FeedPosted by Michael Wonder on 13 Feb 2020
Deciphera Pharmaceuticals announces U.S. FDA acceptance of new drug application and priority review for ripretinib in patients with advanced gastro-intestinal stromal tumour
12 February 2020 - FDA grants priority review and sets PDUFA date of 13 August 2020. ...
Posted by Michael Wonder on 12 Feb 2020
Australia's biotech innovations heading offshore, prompting calls for greater funding to bring them to market
11 February 2020 - The demand on the health sector has never been more evident, as the world scrambles to ...
Posted by Michael Wonder on 12 Feb 2020
FibroGen announces U.S. FDA acceptance of new drug application for roxadustat for the treatment of anaemia of chronic kidney disease
11 February 2020 - FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has completed its filing ...
Posted by Michael Wonder on 12 Feb 2020
Astex Pharmaceuticals announces U.S. FDA acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML
11 February 2020 - FDA designated the application for priority review. ...
Posted by Michael Wonder on 12 Feb 2020
Health Canada has approved Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis)
11 February 2020 - Eli Lilly Canada announced today that Health Canada approved Taltz (ixekizumab) on 4 February 2020, for the ...
Posted by Michael Wonder on 11 Feb 2020
Fennec Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for Pedmark and also submits marketing authorisation application to EMA
11 February 2020 - Pedmark is being developed for prevention of cisplatin-induced hearing loss in children. ...
Posted by Michael Wonder on 11 Feb 2020
Eagle Pharmaceuticals receives final FDA approval for Pemfexy (pemetrexed for injection)
10 February 2020 - Eagle has exclusive rights to commercialise product for four months beginning 1 February 2022. ...
Posted by Michael Wonder on 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
11 February 2020 - Capmatinib review expected to be completed within six months. ...
Posted by Michael Wonder on 11 Feb 2020
Trevena resubmits new drug application for oliceridine
10 February 2020 - Oliceridine is a new chemical entity intended for the management of moderate-to-severe acute pain. ...
Posted by Michael Wonder on 11 Feb 2020
Trump’s 2021 budget request seeks modest funding increase for FDA
10 February 2020 - The Trump administration on Monday unveiled its FY 2021 budget proposal, seeking a 10% reduction in ...
Posted by Michael Wonder on 11 Feb 2020
Aquestive Therapeutics announces U.S. FDA filing acceptance of new drug application for Libervant (diazepam) buccal film
10 February 2020 - Assigned Prescription Drug User Fee Act goal date of 27 September 2020. ...
Posted by Michael Wonder on 11 Feb 2020
Janssen announces submission to U.S. FDA for new Darzalex (daratumumab)-based combination regimen for patients with relapsed/refractory multiple myeloma
10 February 2020 - Application is based on positive data from the Phase 3 CANDOR study, which were presented at the ...
Posted by Michael Wonder on 11 Feb 2020
U.S. FDA grants priority review for Kite’s KTE-X19 biologics license application in relapsed or refractory mantle cell lymphoma
10 February 2020 - If approved, Kite could be first company with multiple commercialised CAR T therapies. ...
Posted by Michael Wonder on 11 Feb 2020
Nanobiotix announces fast track designation granted by U.S. FDA for investigation of first-in-class NBTXR3 in head and neck cancer
10 February 2020 - The U.S. FDA reviewed the Company’s request for fast track designation and concluded that investigation of NBTXR3 ...
Posted by Michael Wonder on 09 Feb 2020
Biosimilars and interchangeable biosimilars: licensure for fewer than all conditions of use for which the reference product has been licensed guidance for industry
5 February 2020 - This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act ...