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RSS FeedPosted by Michael Wonder on 11 Sep 2023
Aquestive Therapeutics receives FDA acceptance of new drug application for Libervant (diazepam) buccal film in paediatric patients and assignment of PDUFA date
11 September 2023 - PDUFA target goal date set for 28 April 2024. ...
Posted by Michael Wonder on 11 Sep 2023
Verona Pharma announces the US FDA has accepted the new drug application filing for ensifentrine for the maintenance treatment of COPD
11 September 2023 - PDUFA target action date of 26 June 2024. ...
Posted by Michael Wonder on 23 Aug 2023
Geron announces PDUFA date for imetelstat NDA in lower risk MDS
22 August 2023 - Geron Corporationtoday announced that the US FDA has assigned a standard review and a PDUFA action date ...
Posted by Michael Wonder on 22 Aug 2023
Swiss drug review times trail FDA and EMA, increased due to COVID
21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...
Posted by Michael Wonder on 14 Aug 2023
Valneva announces PDUFA date extension for Chikungunya virus vaccine candidate
14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...
Posted by Michael Wonder on 27 Jun 2023
UCB provides update on US FDA review of the biologics license application for bimekizumab
26 June 2023 - UCB today announced that the biologics license application for bimekizumab for the treatment of adults with ...
Posted by Michael Wonder on 22 Jun 2023
ARS Pharmaceuticals announces PDUFA date extension for neffy (intranasal epinephrine) for the treatment of allergic reactions (type 1), including anaphylaxis
20 June 2023 - Additional time needed for labelling and post-marketing requirements discussions; PDUFA date set for 19 September 2023. ...
Posted by Michael Wonder on 16 Jun 2023
GSK announces extension of FDA review period for momelotinib
16 June 2023 - GSK today announced that the US FDA has extended the review period of the new drug application ...
Posted by Michael Wonder on 06 Jun 2023
SpringWorks Therapeutics announces PDUFA date extension for nirogacestat NDA
5 June 2023 - FDA extending PDUFA date by three months to allow more time to complete their review; new ...
Posted by Michael Wonder on 21 Apr 2023
Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML extended by FDA
20 April 2023 - Daiichi Sankyo today announced that the US FDA has extended the review period for the new ...
Posted by Michael Wonder on 07 Mar 2023
BioMarin provides update on FDA review of Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...
Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
Posted by Michael Wonder on 20 Feb 2023
Astellas provides update on fezolinetant new drug application in US
20 February 2023 - Astellas Pharma today announced the US FDA notified the company that it is extending the original priority ...
Posted by Michael Wonder on 17 Feb 2023
Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer, expanded Medicare coverage
17 February 2023 - Eisai anticipates about 100,000 patients diagnosed will be eligible for the drug by year three of its ...
Posted by Michael Wonder on 17 Feb 2023
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
16 February 2023 - EMA marketing authorisation application for leniolisib changed to standard review timetable. ...