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RSS FeedPosted by Michael Wonder on 08 Jan 2018
Ionis' inotersen NDA accepted for priority review by the FDA
8 January 2018 - Ionis Pharmaceuticals announced today that its new drug application for inotersen has been accepted for priority review ...
Posted by Michael Wonder on 06 Jan 2018
FDA acceptance of NDA filing for Baremsis for the management of post-operative nausea & vomiting
4 January 2018 - If approved, Baremsis would be the first antiemetic with an indication for rescue treatment of post-operative ...
Posted by Michael Wonder on 06 Jan 2018
Mallinckrodt completes stannsoporfin new drug application filing
4 January 2018 - Mallinckrodt today announced it has successfully completed the rolling submission of a new drug application to ...
Posted by Michael Wonder on 06 Jan 2018
Kala Pharmaceuticals announces new drug application for Inveltys (KPI-121 1%) has been accepted for review by the U.S. FDA
5 January 2018 - PDUFA target action date of 24 August 2018. ...
Posted by Michael Wonder on 04 Jan 2018
Paratek provides update on pipeline progress
3 January 2018 - Rolling NDA submission underway for omadacycline in pneumonia and skin infections. ...
Posted by Michael Wonder on 03 Jan 2018
Trevena announces FDA acceptance for review of new drug application for Olinvo (oliceridine) injection
2 January 2018 - Trevena today announced that the U.S. FDA has accepted the company’s new drug application for Olinvo (oliceridine) ...
Posted by Michael Wonder on 29 Dec 2017
Progenics Pharmaceuticals announces FDA acceptance of new drug application for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
29 December 2017 - Progenics Pharmaceuticals announced today that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 29 Dec 2017
GW Pharmaceuticals announces acceptance of NDA filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
28 December 2017 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 28 Dec 2017
Sun Pharma announces US FDA acceptance of NDA for OTX-101
27 December 2017 - OTX-101 is being evaluated for treatment of dry eye disease. ...
Posted by Michael Wonder on 28 Dec 2017
Portola Pharmaceuticals provides update on biologics license application for AndexXa (andexanet alfa)
22 December 2017 - Portola Pharmaceuticals today announced that the U.S. FDA will extend its review of the biologics license application ...
Posted by Michael Wonder on 27 Dec 2017
Agios submits new drug application to the FDA for ivosidenib for the treatment of patients with relapsed/refractory acute myeloid leukaemia and an IDH1 mutation
26 December 2017 - Ivosidenib has potential to be a first-in-class therapy for patients with relapsed/refractory AML and an IDH1 mutation. ...
Posted by Michael Wonder on 23 Dec 2017
BioMarin receives anticipated notification of PDUFA extension for pegvaliase biologics license application to 28 May 2018
22 December 2017 - Regulatory review process proceeding in-line with company's expectations. ...
Posted by Michael Wonder on 21 Dec 2017
FDA accepts new drug application for Seysara (sarecycline) for the treatment of moderate to severe acne
20 December 2017 - Allergan and Paratek Pharmaceuticals today announced that the U.S. FDA has accepted a new drug application to ...
Posted by Michael Wonder on 21 Dec 2017
Bayer announces initiation of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancers
20 December 2017 - Completion of NDA submission expected in early 2018. ...
Posted by Michael Wonder on 21 Dec 2017
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act Date for TX-004HR
20 December 2017 - PDUFA target action date of 29 May 2018. ...