Blog
RSS FeedPosted 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 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. ...
Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025. ...
Posted by Michael Wonder on 19 Jul 2024
Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose
16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
Posted by Michael Wonder on 09 Jul 2024
Mesoblast resubmits biologics license application with US FDA for approval of Ryoncil in children with steroid-refractory acute graft versus host disease
8 July 2024 - Mesoblast announced today it has resubmitted its BLA for approval of Ryoncil (remestemcel-L) in the treatment ...
Posted by Michael Wonder on 04 Jul 2024
Checkpoint Therapeutics announces biologics license application resubmission for cosibelimab
2 July 2024 - Checkpoint Therapeutics today announced it has completed the resubmission of its biologics license application to the US ...
Posted by Michael Wonder on 03 Jul 2024
Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout
2 July 2024 - Sobi today announced the initiation of a rolling biologics license application to the US FDA for SEL-212. ...