Blog
RSS FeedPosted by Michael Wonder on 02 Mar 2018
FDA to review Dupixent (dupilumab) as potential treatment for moderate-to-severe asthma
2 March 2018 - The U.S. FDA has accepted for review the supplemental biologics license application of Dupixent (dupilumab) as an ...
Posted by Michael Wonder on 01 Mar 2018
Allergan announces FDA has extended the ulipristal acetate NDA review period to August 2018
1 March 2018 - Allergan today announced that it was notified by the U.S. FDA that the review of the new ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 28 Feb 2018
Celgene provides regulatory update on ozanimod for the treatment of relapsing multiple sclerosis
27 February 2018 - Celgene today announced that it has received a refusal to file letter from the United States ...
Posted by Michael Wonder on 27 Feb 2018
Tetraphase Pharmaceuticals announces FDA acceptance for filing of its NDA submission for eravacycline for the treatment of complicated intra-abdominal infections
27 February 2018 - PDUFA date set for 28 August 2018. ...
Posted by Michael Wonder on 27 Feb 2018
Shionogi announces FDA new drug application and EMA marketing authorisation application acceptances for lusutrombopag (S-888711)
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, ...
Posted by Michael Wonder on 24 Feb 2018
Mallinckrodt receives FDA acceptance of stannsoporfin new drug application filing
23 February 2018 - Action date set for 22 August 2018. ...
Posted by Michael Wonder on 22 Feb 2018
FDA acceptance of Medicines360's filing for supplemental new drug application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg
22 February 2018 - Application seeks to extend duration of use up to 5 years for Liletta. ...
Posted by Michael Wonder on 20 Feb 2018
Acorda announces FDA acceptance of new drug application for Inbrija (levodopa inhalation powder)
20 February 2018 - Acorda Therapeutics today announced that the U.S. FDA has accepted for filing its new drug application for ...
Posted by Michael Wonder on 17 Feb 2018
Apricus Biosciences receives complete response letter from FDA for Vitaros
16 February 2018 - Company evaluating deficiencies and potential path forward. ...
Posted by Michael Wonder on 16 Feb 2018
Shire announces FDA acceptance of application for Cinryze (C1 esterase inhibitor [human]) for paediatric hereditary angioedema use
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks ...
Posted by Michael Wonder on 15 Feb 2018
FDA accepts new drug application and grants priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation
15 February 2018 - PDUFA date set for 21 August 2018 ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 12 Feb 2018
Adamis Pharmaceuticals announces FDA acceptance for review for the supplemental new drug application of its low dose Symjepi product candidate
12 February 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has accepted for review the company’s supplemental ...
Posted by Michael Wonder on 12 Feb 2018
U.S. FDA files new drug application under priority review for migalastat for treatment of Fabry disease
12 February 2018 - Six month PDUFA goal date is 13 August 2018. ...