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RSS FeedPosted by Michael Wonder on 30 Mar 2021
Akebia submits new drug application to the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis and not on dialysis
30 March 2021 - Akebia Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 30 Mar 2021
U.S. FDA accepts AbbVie's new drug application for atogepant for the preventive treatment of migraine
30 March 2021 - If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the ...
Posted by Michael Wonder on 29 Mar 2021
TG Therapeutics completes rolling submission of biologics license application to the U.S. FDA for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia
29 March 2021 - TG Therapeutics today announced the completion of the rolling submission of a biologics license application to the ...
Posted by Michael Wonder on 29 Mar 2021
Mirum Pharmaceuticals announces FDA acceptance of new drug application and priority review for maralixibat in Alagille syndrome
29 March 2021 - PDUFA action date is 29 September 2021. ...
Posted by Michael Wonder on 29 Mar 2021
Mezzion announces resubmission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
28 March 2021 - Submitted for FDA priority review as a rare paediatric disease product application. ...
Posted by Michael Wonder on 23 Mar 2021
Novo Nordisk receives refusal to file letter for once weekly semaglutide 2 mg for the treatment of type 2 diabetes
22 March 2021 - Novo Nordisk today announced that the US FDA has issued a refusal to file letter covering the ...
Posted by Michael Wonder on 19 Mar 2021
U.S. FDA accepts Bristol Myers Squibb’s application for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy
19 March 2021 - Application based on results from the Phase 3 EXPLORER-HCM trial. ...
Posted by Michael Wonder on 17 Mar 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of adults with active psoriatic arthritis
17 March 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 16 Mar 2021
Merck receives priority review from FDA for new drug application for HIF-2α inhibitor belzutifan (MK-6482)
16 March 2021 - Application based on objective response rate from Phase 2 trial evaluating belzutifan in patients with von Hippel-Lindau ...
Posted by Michael Wonder on 15 Mar 2021
Confirmation of Technigas US FDA timetable
12 March 2021 - Cyclopharm has provided an update of the US FDA’s timetable in respect of approval of the Company’s ...
Posted by Michael Wonder on 15 Mar 2021
Calliditas announces submission of new drug application to U.S. FDA for Nefecon in patients with primary IgA nephropathy
15 March 2021 - Calliditas Therapeutics today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 13 Mar 2021
Marius Pharmaceuticals receives PDUFA date for Kyzatrex NDA for treatment of hypogonadism
11 March 2021 - Marius Pharmaceuticals announced today that the U.S. FDA has assigned a Prescription Drug User Fee Act goal ...
Posted by Michael Wonder on 11 Mar 2021
Kadmon announces U.S. FDA has extended the review period for belumosudil in chronic graft versus host disease
10 March 2021 - Kadmon today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 10 Mar 2021
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia
10 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on ...
Posted by Michael Wonder on 10 Mar 2021
U.S. FDA accepts UVision360 submission for novel Luminelle DTx system biopsy sheath
9 March 2021 - UVision360 announces today that the U.S. FDA has accepted the Company's submission to expand the Luminelle DTx ...