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RSS FeedPosted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, ...
Posted by Michael Wonder on 27 Apr 2021
Reata announces FDA accepted for filing the NDA for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome
26 April 2021 - Application assigned a PDUFA date of 25 February 2022. ...
Posted by Michael Wonder on 26 Apr 2021
Axsome Therapeutics announces FDA acceptance and priority review of new drug application for AXS-05 for treatment of major depressive disorder
26 April 2021 - FDA grants priority review and sets PDUFA action goal date of 22 August 2021. ...
Posted by Michael Wonder on 20 Apr 2021
Biocartis announces US FDA 510(k) submission of its Idylla MSI test
20 April 2021 - First US FDA oncology assay submission for Biocartis. ...
Posted by Michael Wonder on 20 Apr 2021
Alnylam submits new drug application with U.S. FDA for vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults
19 April 2021 - Alnylam has submitted a new drug application to the U.S. FDA for the approval of vutrisiran for ...
Posted by Michael Wonder on 19 Apr 2021
United Therapeutics announces submission of Tvyaso DPI new drug application to FDA
19 April 2021 - Priority review voucher applied to the submission. ...
Posted by Michael Wonder on 19 Apr 2021
Seagen and Astellas announce U.S. FDA acceptance of two supplemental biologics license applications for Padcev (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer
19 April 2021 - Australia and Canada regulators will review applications as part of FDA’s Project Orbis. ...
Posted by Michael Wonder on 13 Apr 2021
Avenue Therapeutics announces that the FDA is still reviewing its NDA resubmission for IV tramadol
13 April 2021 - The FDA has not provided a decision regarding the new drug application. ...
Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...
Posted by Michael Wonder on 12 Apr 2021
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia
12 April 2021 - Final FDA decision anticipated by 12 August. ...
Posted by Michael Wonder on 09 Apr 2021
Pfizer requests FDA clearance for vaccine in kids ages 12 to 15
9 April 2021 - The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine ...
Posted by Michael Wonder on 09 Apr 2021
Genmab and Seagen announce U.S. FDA filing acceptance for priority review of tisotumab vedotin biologics license application for patients with recurrent or metastatic cervical cancer
9 April 2021 - BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical ...
Posted by Michael Wonder on 09 Apr 2021
Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. ...
Posted by Michael Wonder on 07 Apr 2021
AbbVie submits regulatory applications for Skyrizi (risankizumab) in psoriatic arthritis to FDA and EMA
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...
Posted by Michael Wonder on 07 Apr 2021
Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis
7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new ...