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RSS FeedPosted by Michael Wonder on 07 Dec 2022
Ocuphire Pharma announces submission of new drug application to FDA for Nyxol eye drops for reversal of mydriasis
6 December 2022 - NDA supported by positive Phase 3 data demonstrating rapid reversal of dilated eyes and favourable safety profile ...
Posted by Michael Wonder on 07 Dec 2022
Sage Therapeutics and Biogen complete rolling submission of new drug application for zuranolone in the treatment of major depressive disorder and post-partum depression
6 December 2022 - Zuranolone is being evaluated as a short course, rapid-acting, oral medication for major depressive disorder (MDD) and ...
Posted by Michael Wonder on 06 Dec 2022
Ionis announces European Medicines Agency accepts marketing authorisation application of tofersen to treat rare, genetic form of ALS
5 December 2022 - EMA acceptance follows FDA's acceptance of tofersen new drug application earlier this year. ...
Posted by Michael Wonder on 04 Dec 2022
EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children
2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...
Posted by Michael Wonder on 03 Dec 2022
Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)
1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...
Posted by Michael Wonder on 03 Dec 2022
European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
Posted by Michael Wonder on 03 Dec 2022
EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
Posted by Michael Wonder on 02 Dec 2022
Y-mAbs announces complete response letter for omburtamab biologics license application
1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 01 Dec 2022
Citius Pharmaceuticals announces US FDA acceptance of biologics license application of denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma
1 December 2022 - PDUFA target action date is 28 September 2023. ...
Posted by Michael Wonder on 01 Dec 2022
Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...
Posted by Michael Wonder on 30 Nov 2022
Evkeeza (evinacumab-dgnb) sBLA for children with ultra rare inherited form of high cholesterol accepted for FDA priority review
30 November 2022 - If approved, Evkeeza would be the first and only treatment of its kind to help children ...
Posted by Michael Wonder on 30 Nov 2022
Aldeyra Therapeutics submits new drug application to the US FDA for reproxalap for the treatment of signs and symptoms of dry eye disease
29 November 2022 - Aldeyra Therapeutics today announced the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 28 Nov 2022
Sarepta Therapeutics announces that US FDA has accepted for filing and granted priority review for the biologics license application for SRP-9001, Sarepta’s gene therapy for the treatment of ambulant individuals with Duchenne muscular dystrophy
28 November 2022 - Regulatory action date of 29 May 2023. ...
Posted by Michael Wonder on 26 Nov 2022
GSK Canada submits respiratory syncytial virus vaccine candidate for regulatory review
25 November 2022 - Application includes important pivotal Phase 3 data evaluating the efficacy and safety of our vaccine candidate against ...
Posted by Michael Wonder on 25 Nov 2022
Spectrum Pharmaceuticals receives complete response letter from US Food and Drug Administration for poziotinib
25 November 2022 - Spectrum Pharmaceuticals today announced that the Company has received a complete response letter from the US FDA ...