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RSS FeedPosted by Michael Wonder on 31 Jul 2024
PTC Therapeutics announces sepiapterin NDA submission to FDA
30 July 2024 - PTC Therapeutics announced today the submission of the sepiapterin new drug application to the US FDA. ...
Posted by Michael Wonder on 30 Jul 2024
FDA accepts Telix NDA for new prostate cancer imaging agent
23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...
Posted by Michael Wonder on 30 Jul 2024
Vertex announces FDA acceptance of new drug application for suzetrigine for the treatment of moderate to severe acute pain
30 July 2024 - FDA grants priority review and assigns a PDUFA target action date of 30 January 2025. ...
Posted by Michael Wonder on 30 Jul 2024
Novartis Scemblix granted FDA priority review for the treatment of adults with newly diagnosed CML
29 July 2024 - Priority review based on ASC4FIRST Phase 3 study with Scemblix data first to show significantly improved molecular ...
Posted by Michael Wonder on 30 Jul 2024
Syndax announces PDUFA action date extension for revumenib NDA for relapsed or refractory KMT2Ar acute leukaemia
29 July 2024 - New PDUFA action date of 26 December 2024 allows FDA additional time to complete their review. ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 26 Jul 2024
Checkpoint Therapeutics announces FDA acceptance of BLA resubmission of cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma
25 July 2024 - PDUFA goal date of 28 December 2024 set by FDA. ...
Posted by Michael Wonder on 26 Jul 2024
Arcutis submits supplemental new drug application for Zorvye (roflumilast) foam to the FDA for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
23 July 2024 - Once daily Zorvye foam significantly improved both scalp and body psoriasis in a Phase 2b and a ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 24 Jul 2024
FDA accepts Mesoblast's biologics license application for Ryoncil in children with steroid-refractory acute graft versus host disease
23 July 2024 - Mesoblast announced that the US FDA has accepted its biologics license application resubmission for Ryoncil (remestemcel-L) ...
Posted by Michael Wonder on 23 Jul 2024
Johnson & Johnson seeks US FDA approval of Spravato (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
22 July 2024 - Phase 4 Spravato monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at ...
Posted by Michael Wonder on 20 Jul 2024
EMA accepts Deciphera’s marketing authorisation application for vimseltinib for treatment of patients with tenosynovial giant cell tumour
18 July 2024 - Application based on results from the MOTION Phase 3 study, in which vimseltinib demonstrated statistically significant and ...
Posted by Michael Wonder on 20 Jul 2024
Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the EMA
19 July 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials. ...
Posted by Michael Wonder on 19 Jul 2024
Bristol Myers Squibb receives EMA validation of application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of unresectable or advanced hepatocellular carcinoma
19 July 2024 - The Application is based on Phase 3 CheckMate-9DW trial results demonstrating improved survival with Opdivo plus ...
Posted by Michael Wonder on 19 Jul 2024
Lexicon Pharmaceuticals receives 20 December 2024 PDUFA goal date for sotagliflozin type 1 diabetes NDA resubmission
16 July 2024 - Launch preparations actively underway; launch planned for early 2025. ...