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RSS FeedPosted by Michael Wonder on 31 Jul 2017
Amgen submits supplemental biologics license application for Prolia (denosumab) in glucocorticoid-induced osteoporosis
31 July 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA for Prolia ...
Posted by Michael Wonder on 31 Jul 2017
Amgen and Allergan submit biosimilar biologics license application for ABP 980 to US Food And Drug Administration
31 July 2017 - Filing for ABP 980, a biosimilar candidate to Herceptin (trastuzumab), supported by phase 3 data in ...
Posted by Michael Wonder on 30 Jul 2017
FDA accepts biologics license application for Aimovig (erenumab)
20 July 2017 - Aimovig is an Investigative migraine-specific preventive therapy designed for patients with high unmet need. ...
Posted by Michael Wonder on 29 Jul 2017
Lundbeck and Takeda receive complete response letter from the FDA for Trintellix (vortioxetine) sNDA
23 June 2017 - Lundbeck and Takeda today announced that after providing additional analysis, the U.S. FDA has issued a ...
Posted by Michael Wonder on 29 Jul 2017
U.S. FDA grants priority review for an epinephrine auto-injector in development by Kaléo specifically for infants and small children
27 July 2017 - AUVI-Q (epinephrine injection) 0.1 mg could be the first auto-injector approved with a needle length and dose ...
Posted by Michael Wonder on 29 Jul 2017
FDA grants priority review for Amgen's supplemental biologics license application for Repatha (evolocumab) to include data on reducing risk of cardiovascular events
28 July 2017 - FDA priority review status underscores need to reduce heart attacks and strokes. ...
Posted by Michael Wonder on 28 Jul 2017
Aradigm submits new drug application to FDA for U.S. marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
27 July 2017 - Aradigm Corporation today announced it has submitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 26 Jul 2017
UCB and Dermira announce U.S. and EU regulatory submissions for Cimzia (certolizumab pegol) for the treatment of moderate-to-severe chronic plaque psoriasis
25 July 2017 - The regulatory submissions for this new indication seek to expand the use of Cimzia for the treatment ...
Posted by Michael Wonder on 25 Jul 2017
Lilly and Incyte provide update on baricitinib
25 July 2017 - Eli Lilly and Incyte Corporation announced today that a resubmission to the U.S. FDA for the ...
Posted by Michael Wonder on 25 Jul 2017
GSK submits US regulatory filing of Arnuity Ellipta in children with asthma
24 July 2017 - GSK today announced the filing of a supplementary new drug application to the US FDA for the ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA accepts Bristol-Myers Squibb’s applications for Opdivo (nivolumab) four-week dosing schedule across all approved indications
24 July 2017 - Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license applications to update ...
Posted by Michael Wonder on 23 Jul 2017
Braeburn and Camurus announce submission for CAM2038 for opioid use disorder
20 July 2017 - Priority review of the NDA has been applied for which, if granted, would shorten the review process ...
Posted by Michael Wonder on 18 Jul 2017
Spark Therapeutics’ biologics license application for investigational voretigene neparvovec accepted for filing by FDA
17 July 2017 - FDA grants priority review with PDUFA date of 12 January 2018. ...
Posted by Michael Wonder on 17 Jul 2017
Amgen and UCB provide update on regulatory status of Evenity (romosozumab) in the US
16 July 2017 - Amgen and UCB today announced that the U.S. FDA has issued a complete response letter for ...
Posted by Michael Wonder on 17 Jul 2017
Amgen submits regulatory applications in US and Europe to include overall survival data in Kyprolis (carfilzomib) label
14 July 2017 - Data showed Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall survival ...