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RSS FeedPosted by Michael Wonder on 21 Nov 2022
Moderna applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine
18 November 2022 - Application submitted for Spikevax Bivalent Original / Omicron BA.4-5 (mRNA-1273.222) ...
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 18 Nov 2022
Calliditas' partner Everest Medicine's new drug application for Nefecon is accepted by the China NMPA
15 November 2022 - Calliditas Therapeutics today announced that the Chinese regulatory authority NMPA has accepted Everest Medicines' new drug application ...
Posted by Michael Wonder on 17 Nov 2022
Napp announces acceptance of their rezafungin marketing authorisation application for the treatment of invasive candidiasis to the UK Medicines and Healthcare Products Regulatory Agency
16 November 2022 - The MHRA filing is supported by the pivotal ReSTORE Phase 3 clinical trial results, where rezafungin demonstrated ...
Posted by Michael Wonder on 15 Nov 2022
Junshi Biosciences announces submission of a marketing authorisation application to the European Medicines Agency for toripalimab
14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...
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. ...
Posted by Michael Wonder on 11 Nov 2022
Cannabidiol for the treatment of patients with seizures caused by tuberous sclerosis complex
8 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 10 Nov 2022
BrainStorm Cell Therapeutics receives refusal to file letter from FDA for its new biologics license application for NurOwn for the treatment of ALS
10 November 2022 - BrainStorm Cell Therapeutics today announced that the company has received a refusal to file letter from the ...
Posted by Michael Wonder on 10 Nov 2022
BioLineRx announces US FDA acceptance of new drug application for Aphexda (motixafortide) in stem cell mobilisation
10 November 2022 - PDUFA target action date set for 9 September 2023. ...
Posted by Michael Wonder on 08 Nov 2022
BioMarin announces incremental progress on biologics license application review for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A program
7 November 2022 - FDA requests submission of upcoming 3 year data analysis from Phase 3 GENEr8-1 trial. ...
Posted by Michael Wonder on 04 Nov 2022
MedinCell’s partner Teva today announced refiling for approval of mdc-IRM and confirmed planned launch in the US in H1 2023
3 November 2022 - MedinCell’s partner, Teva, today announced that it recently completed the re-submission to a new drug application ...
Posted by Michael Wonder on 04 Nov 2022
Beyfortus approved in the EU for the prevention of RSV lower respiratory tract disease in infants
4 November 2022 - European Commission grants first approval worldwide following positive CHMP opinion in September. ...
Posted by Michael Wonder on 04 Nov 2022
Iveric Bio announces submission of first part of NDA for rolling review of avacincaptad pegol for the treatment of geographic atrophy
3 November 2022 - IVERIC bio today announced that it has submitted to the US FDA the first part of ...