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RSS FeedPosted by Michael Wonder on 14 Sep 2017
Teva receives FDA priority review for first line use of Trisenox (arsenic trioxide) in patients with low to intermediate risk acute promyelocytic leukaemia
12 September 2017 - Teva Pharmaceutical Industries announced today the U.S. FDA has accepted for review the company’s supplemental new ...
Posted by Michael Wonder on 13 Sep 2017
KemPharm announces FDRR process completion and resubmission of the Apadaz NDA
12 September 2017 - FDA has assigned a PDUFA action date of 23 February 2018. ...
Posted by Michael Wonder on 12 Sep 2017
FDA accepts Adello’s biosimilar biologics license application for a proposed filgrastim biosimilar
11 September 2017 - U.S.-based Adello Biologics today announced that U.S. FDA has accepted for review the company’s biologics license ...
Posted by Michael Wonder on 12 Sep 2017
Sandoz proposed biosimilar rituximab accepted for review by the FDA
12 September 2017 - Sandoz believes the comprehensive data package submitted to the FDA for review confirms that our biosimilar rituximab ...
Posted by Michael Wonder on 06 Sep 2017
AbbVie submits new drug application to U.S. FDA for investigational oral treatment elagolix for the management of endometriosis with associated pain
6 September 2017 - If approved by the FDA, elagolix will be the first new medical management treatment option for endometriosis-associated ...
Posted by Michael Wonder on 03 Sep 2017
SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
31 August 2017 - Company to meet and work with FDA to address issues raised. ...
Posted by Michael Wonder on 03 Sep 2017
Bayer submits biologics license application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of haemophilia A
31 August 2017 - Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals. ...
Posted by Michael Wonder on 03 Sep 2017
FDA accepts Amgen's filing of a supplemental new drug application to add overall survival results to Kyprolis (carfilzomib) label
30 August 2017 - FDA sets PDUFA target action date of 30 April 2018 ...
Posted by Michael Wonder on 02 Sep 2017
Apricus Biosciences announces FDA acknowledgement of Vitaros Class 2 NDA resubmission
31 August 2017 - Apricus Biosciences today announced that the U.S. FDA has acknowledged receipt of its recently resubmitted new drug ...
Posted by Michael Wonder on 31 Aug 2017
USFDA target action date for trastuzumab reset to 3 December 2017
30 August 2017 - The US FDA has notified our partner Mylan that they will extend the target action date for ...
Posted by Michael Wonder on 31 Aug 2017
Advanced Accelerator Applications announces New Prescription Drug User Fee Act date of 26 January 2018 for Lutetium Lu 177 dotatate (Lutathera)
28 August 2017 - Advanced Accelerator Applications today announced that the US FDA has acknowledged receipt and considered complete the resubmission ...
Posted by Michael Wonder on 30 Aug 2017
FDA accepts BioMarin's pegvaliase biologics license application and grants priority review designation
29 August 2017 - BioMarin Pharmaceutical today announced that the U.S. FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 30 Aug 2017
Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018
30 August 2017 - Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. FDA in ...
Posted by Michael Wonder on 29 Aug 2017
U.S. FDA and EMA accept regulatory submissions for Bosulif (bosutinib) for the treatment of patients with newly diagnose Ph+ chronic myeloid leukaemia
29 August 2017 - Applications seek to expand approved use of Bosulif into first- line treatment based on positive results from ...
Posted by Michael Wonder on 29 Aug 2017
Acorda receives refusal to file letter from FDA for Inbrija (CVT-301, levodopa inhalation powder) new drug application
29 August 2017 - Acorda Therapeutics today announced that it received a refusal to file letter from the U.S. FDA ...