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RSS FeedPosted by Michael Wonder on 26 Sep 2018
Neurelis files new drug application with the FDA for Valtoco nasal spray, an investigational treatment for paediatric, adolescent and adult epilepsy patients
25 September 2018 - Neurelis today announced that the company has submitted a new drug application with the U.S. FDA for ...
Posted by Michael Wonder on 19 Sep 2018
Janssen submits new drug application to U.S. FDA seeking approval of erdafitinib for the treatment of metastatic urothelial cancer
18 September 2018 - Janssen announced today that a new drug application has been submitted to the U.S. FDA seeking ...
Posted by Michael Wonder on 14 Sep 2018
Acorda announces FDA extends Inbrija NDA review period
13 September 2018 - New PDUFA date of 5 January 2019. ...
Posted by Michael Wonder on 13 Sep 2018
FDA to review Eylea (aflibercept) injection for the treatment of diabetic retinopathy
13 September 2018 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental biologics license application ...
Posted by Michael Wonder on 13 Sep 2018
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumours express PD-L1 (TPS ≥1%)
12 September 2018 - Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial. ...
Posted by Michael Wonder on 12 Sep 2018
FDA to review supplemental biologics license application for Praluent (alirocumab) injection as potential treatment to reduce major adverse cardiovascular events
12 September 2018 - FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy. ...
Posted by Michael Wonder on 05 Sep 2018
Dova Pharmaceuticals submits supplemental new drug application for Doptelet (avatrombopag) for the treatment of chronic ITP
4 September 2018 - Dova Pharmaceuticals today announced the submission of a supplemental new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 04 Sep 2018
Janssen submits esketamine nasal spray new drug application to U.S. FDA for treatment-resistant depression
4 September 2018 - Janssen today announced the submission of a new drug application to the U.S. FDA for esketamine ...
Posted by Michael Wonder on 30 Aug 2018
FDA accepts resubmission of new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
29 August 2018 - Ortho Dermatologics today announced that the U.S. FDA has accepted the resubmitted new drug application for Duobrii ...
Posted by Michael Wonder on 29 Aug 2018
Evolus receives acceptance of FDA BLA resubmission for DWP-450
29 August 2018 - Application designated as Class 2 by U.S. FDA and assigned 2 February 2019 PDUFA date. ...
Posted by Michael Wonder on 27 Aug 2018
Amgen submits supplemental new drug application for Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone
27 August 2018 - Filing based on data from Phase 3 head-to-head A.R.R.O.W. study. ...
Posted by Michael Wonder on 23 Aug 2018
Novimmune submits marketing authorisation application in Europe for its lead drug emapalumab
22 August 2018 - Novimmune today announced that it has successfully submitted a marketing authorisation application to the EMA seeking marketing ...
Posted by Michael Wonder on 16 Aug 2018
Ortho Dermatologics resubmits U.S. new drug application for Duobrii (halobetasol propionate and tazarotene) lotion
15 August 2018 - Ortho Dermatologics, a division of Bausch Health, today announced it has resubmitted a new drug application to ...
Posted by Michael Wonder on 14 Aug 2018
Motif Bio announces FDA acceptance of new drug application with priority review for iclaprim for treatment of acute bacterial skin and skin structure infections
14 August 2018 - PDUFA action date set for 13 February 2019. ...
Posted by Michael Wonder on 13 Aug 2018
FDA accepts new drug application to review midazolam nasal spray, an investigational product for the acute treatment of seizure clusters
13 August 2018 - Midazolam nasal spray has also been granted fast track designation by the US FDA due to the ...