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RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 04 Nov 2022
Apellis announces plans to submit 24 month Phase 3 data to the FDA for pegcetacoplan NDA for geographic atrophy
3 November 2022 - Submission will be a major amendment to the new drug application, extending the review period by ...
Posted by Michael Wonder on 02 Nov 2022
GSK’s respiratory syncytial virus older adult vaccine candidate granted priority review by US FDA
2 November 2022 - US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023. ...
Posted by Michael Wonder on 01 Nov 2022
Salvat Laboratories announces submission of new drug application to the US FDA for clobetasol nanoemulsion for treating inflammation and pain after ocular surgery
25 October 2022 - Salvat Laboratories today announced that it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 31 Oct 2022
FDA accepts for priority review Ascendis Pharma’s NDA for TransCon PTH in adult patients with hypoparathyroidism
31 October 2022 - PDUFA target action date is 30 April 2023. ...
Posted by Michael Wonder on 30 Oct 2022
CytoDyn announces voluntary withdrawal of BLA for HIV-MDR due to CRO data management issues
28 October 2022 - Company to complete and submit responses to FDA clinical hold. ...
Posted by Michael Wonder on 28 Oct 2022
US FDA defers action on filing for AT-GAA in late-onset Pompe disease
28 October 2022 - FDA issues deferred action letter on AT-GAA regulatory filing due to the inability to conduct required manufacturing ...
Posted by Michael Wonder on 28 Oct 2022
Outlook Therapeutics announces acceptance of biologics license application by U.S. FDA for ONS-5010 as a treatment for wet AMD
28 October 2022 - Prescription Drug User Fee Act goal date of 29 August 2023. ...
Posted by Michael Wonder on 28 Oct 2022
AbbVie announces submissions of regulatory applications for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory diffuse large B-cell lymphoma and large B-cell lymphoma
28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA. ...
Posted by Michael Wonder on 27 Oct 2022
Santhera and ReveraGen complete NDA submission to FDA for vamorolone in Duchenne muscular dystrophy
27 October 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce that they have completed the rolling submission of a new drug ...
Posted by Michael Wonder on 26 Oct 2022
US FDA delays panel meet on Perrigo's OTC birth control pill
26 October 2022 - The US FDA has delayed a meeting of its advisory panel to discuss Perrigo's over the ...