Blog
RSS FeedPosted by Michael Wonder on 06 Apr 2021
Lilly and Incyte communicate review extension of supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
6 April 2021 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...
Posted by Michael Wonder on 06 Apr 2021
Biofrontera submits application for FDA approval of new BF-RhodoLED XL lamp
31 March 2021 - Biofrontera today announced the submission for approval of a new, significantly larger red-light source for photodynamic therapy ...
Posted by Michael Wonder on 06 Apr 2021
Kite submits supplemental biologics license application to U.S. FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukaemia
1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients ...
Posted by Michael Wonder on 05 Apr 2021
BeyondSpring announces submission of new drug application to U.S. FDA and China NMPA for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia
31 March 2021 - Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers ...
Posted by Michael Wonder on 02 Apr 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of moderate to severe atopic dermatitis
2 April 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted 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 ...