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RSS FeedPosted by Michael Wonder on 05 Oct 2019
DBV Technologies announces FDA acceptance of BLA filing for Viaskin Peanut for the treatment of peanut allergy
4 October 2019 - If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening ...
Posted by Michael Wonder on 03 Oct 2019
Janssen submits supplemental new drug application to U.S. FDA for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adults with major depressive disorder who have active suicidal ideation with intent
2 October 2019 - If approved, Spravato would be the first treatment for this severely ill population who historically have been ...
Posted by Michael Wonder on 02 Oct 2019
U.S. FDA submission of new drug application for NS-065/NCNP-01 (viltolarsen)
2 October 2019 - Nippon Shinyaku announced that it has completed the submission of its rolling new drug application to the ...
Posted by Michael Wonder on 02 Oct 2019
GSK submits filing to FDA for Trelegy Ellipta use in patients with asthma
2 October 2019 - GSK and Innoviva today announced the filing of a supplemental new drug application to the US ...
Posted by Michael Wonder on 02 Oct 2019
FDA accepts two applications for Merck’s Dificid (fidaxomicin) to treat children aged six months up to 18 years with Clostridium difficile infections
2 October 2019 - Dificid paediatric filings receive priority review classification. ...
Posted by Michael Wonder on 01 Oct 2019
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the management of post-operative pain
1 October 2019 - Heron Therapeutics today announced that it has resubmitted its new drug application to the U.S. FDA ...
Posted by Michael Wonder on 28 Sep 2019
Intercept submits new drug application to the U.S. FDA for obeticholic acid in patients with fibrosis due to NASH
27 September 2019 - NDA supported by positive interim analysis results from REGENERATE Phase 3 study demonstrating OCA’s improvement of liver ...
Posted by Michael Wonder on 27 Sep 2019
IntelGenx announces resubmission of Rizaport new drug application
26 September 2019 - IntelGenx today announced that it has resubmitted its 505(b)(2) new drug application for Rizaport VersaFilm for the ...
Posted by Michael Wonder on 26 Sep 2019
Acacia Pharma announces new Barhemsys PDUFA target date of 26 February 2020
26 September 2019 - This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation ...
Posted by Michael Wonder on 18 Sep 2019
Vertical Pharmaceuticals announces submission of new drug application for RVL-1201
17 September 2019 - Vertical Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...
Posted by Michael Wonder on 16 Sep 2019
Verrica Pharmaceuticals submits new drug application to U.S. FDA for VP-102 for the treatment of molluscum contagiosum
16 September 2019 - No FDA approved treatments are currently available for this highly contagious, primarily paediatric, viral skin infection affecting ...
Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 16 Sep 2019
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis
16 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...
Posted by Michael Wonder on 11 Sep 2019
Puma Biotechnology announces U.S. FDA acceptance of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer
11 September 2019 - Puma Biotechnology announced that the U.S. FDA has accepted for review its supplemental new drug application for ...