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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 07 Feb 2020
Revance announces U.S. FDA acceptance of biologics license application for DAXI to treat glabellar (frown) lines
6 February 2020 - Prescription Drug User Fee Act target action date of 25 November 2020. ...
Posted by Michael Wonder on 07 Feb 2020
Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour
6 February 2020 - PDUFA action date extended by three months to 14 May 2020. ...
Posted by Michael Wonder on 05 Feb 2020
Alector announces FDA fast track designation granted to AL101 for the treatment of patients with frontotemporal dementia
5 February 2020 - Alector today announced that the U.S. FDA has granted fast track designation to AL101 for the treatment ...
Posted by Michael Wonder on 05 Feb 2020
Orsini Pharmaceutical Services now providing FDA approved Vyondys 53 (golodirsen) injection for Duchenne muscular dystrophy
5 February 2020 - Commercial distribution of Vyondys 53 in the U.S. is currently underway. ...