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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 24 Nov 2022
Camurus announces that Braeburn resubmits NDA for Brixadi in the US
23 November 2022 - Camurus today announced that its US licensee Braeburn has resubmitted the new drug application for Brixadi (buprenorphine) ...
Posted by Michael Wonder on 23 Nov 2022
BioMarin announces advancements in FDA review of Roctavian (valoctocogene roxaparvovec) for adults with severe haemophilia A
23 November 2022 - FDA no longer plans to hold an advisory committee meeting, as previously planned, to discuss the biologics ...
Posted by Michael Wonder on 23 Nov 2022
Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of indolent systemic mastocytosis
22 November 2022 - Blueprint Medicines today announced the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 22 Nov 2022
IntelGenx receives FDA PDUFA date for Rizafilm
22 November 2022 - IntelGenx today announced that the US FDA has accepted for review its Class 2 response to the ...
Posted by Michael Wonder on 22 Nov 2022
Gamida Cell provides regulatory update on omidubicel
21 November 2022 - Recent company submission in response to FDA request extends PDUFA date by three months. ...
Posted by Michael Wonder on 22 Nov 2022
UCB submits response to FDA complete response letter for bimekizumab
22 November 2022 - UCB today announced that it has resubmitted the biologics license application to the US FDA for ...
Posted by Michael Wonder on 22 Nov 2022
argenx announces US FDA acceptance of biologics license application for subcutaneous efgartigimod in generalised myasthenia gravis with priority review
22 November 2022 - PDUFA target action date is 20 March 2023. ...
Posted by Michael Wonder on 21 Nov 2022
US FDA accepts for priority review the biologics license application for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma
21 November 2022 - The application is supported by data from EPCORE NHL-1 Phase 1/2 trial evaluating the safety and preliminary ...
Posted by Michael Wonder on 19 Nov 2022
Iovance Biotherapeutics provides update on biologics license application submission for lifileucel in advanced melanoma
18 November 2022 - BLA submission on-going with US FDA. ...
Posted by Michael Wonder on 19 Nov 2022
Apellis announces FDA acceptance of NDA amendment and new PDUFA date of 26 February 2023 for pegcetacoplan for geographic atrophy
18 November 2022 - Apellis Pharmaceuticals today announced that the US FDA has accepted Apellis’ unsolicited major amendment to the new ...
Posted by Michael Wonder on 14 Nov 2022
UCB announces US FDA acceptance of new drug application and EMA MAA validation for zilucoplan for the treatment of generalized myasthenia gravis in adult patients
14 November 2022 - New drug application for zilucoplan seeks approval for the treatment of generalised myasthenia gravis in adult patients ...
Posted by Michael Wonder on 11 Nov 2022
Amneal announces US FDA filing acceptance of new drug application for IPX203 for the treatment of Parkinson’s disease
11 November 2022 - The FDA has assigned a PDUFA date of 30 June 2023. ...