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RSS FeedPosted by Michael Wonder on 30 Aug 2016
FDA accepts CSL Behring’s BLA for first subcutaneous prophylactic therapy to prevent hereditary angioedema attacks
30 August 2016 - CSL today announced that the US FDA has accepted for review CSL Behring’s biologics license application for ...
Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies. ...
Posted by Michael Wonder on 22 Aug 2016
Sanofi provides update on new drug application for investigational once-daily fixed-ratio combination of insulin glargine and lixisenatide
19 August 2016 - Sanofi announced today that it has submitted updated information on the pen delivery device as part ...
Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma. ...
Posted by Michael Wonder on 11 Aug 2016
FDA accepts Marathon Pharmaceuticals’ new drug applications for deflazacort for the treatment of Duchenne muscular dystrophy and grants priority review
10 August 2016 - Deflazacort could be among the first FDA approved treatments for this devastating genetic disorder. ...
Posted by Michael Wonder on 08 Aug 2016
Merck announces U.S. FDA filing acceptance of new drug application for MK-1293, an investigational follow-on biologic insulin glargine
5 August 2016 - Marketing authorization application to the European Medicines Agency currently under review. ...
Posted by Michael Wonder on 06 Aug 2016
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
5 August 2016 - The U.S. FDA today issued draft updated recommendations to help manufacturers determine when they are required to ...
Posted by Michael Wonder on 02 Aug 2016
FDA accepts BLA for BioMarin's cerliponase alfa for CLN2 disease, form of Batten disease
27 July 2016 - Potential first treatment for fatal, rare, brain disease in children. ...
Posted by Michael Wonder on 27 Jul 2016
FDA continues steady reduction of generic drug application backlog
25 July 2016 - As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US FDA ...
Posted by Michael Wonder on 22 Jul 2016
Merck provides regulatory update on biologics licensing application for investigational agent bezlotoxumab
22 July 2016 - Merck today said that the U.S. FDA has requested the submission of new data and analyses from ...
Posted by Michael Wonder on 18 Jul 2016
Bristol-Myers Squibb announces regulatory updates for Opdivo (nivolumab) in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
18 July 2016 - Bristol-Myers Squibb Company announced today U.S. and European marketing applications to expand the use of Opdivo for ...
Posted by Michael Wonder on 28 Jun 2016
Roche’s marketing applications for review of Ocrevus (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
28 June 2016 - Ocrevus is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis. ...
Posted by Michael Wonder on 21 Jun 2016
Mitsubishi Tanabe Pharma submits new drug application for edaravone to treat ALS in the United States
20 June 2016 - Mitsubishi Tanabe Pharma Corporation today announced that a new drug application has been submitted to the ...
Posted by Michael Wonder on 20 Jun 2016
Ariad initiates submission of new drug application for brigatinib to the U.S. FDA ahead of plan
17 June 2016 - Ariad Pharmaceuticals today announced the initiation of a new drug application submission for its investigational anaplastic lymphoma ...
Posted by Michael Wonder on 16 Jun 2016
Charleston Laboratories and Daiichi Sankyo announce FDA acceptance of new drug application for CL-108
13 June 2016 – Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. today announced that the U.S. FDA has accepted for ...