Blog
RSS FeedPosted by Michael Wonder on 13 May 2024
Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis
13 May 2024 - If approved, Dupixent would be the first treatment in the US indicated for adolescents aged 12-17 years ...
Posted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 06 May 2024
Merus announces US FDA acceptance and priority review of biologics license application for zenocutuzumab for the treatment of NRG1 positive NSCLC and PDAC
6 May 2024 - If approved, zenocutuzumab will be the first targeted therapy for NRG1 positive cancer. ...
Posted by Michael Wonder on 06 May 2024
US FDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase)
6 May 2024 - Application based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab ...
Posted by Michael Wonder on 06 May 2024
EMA validates Bristol Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer
6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
Posted by Michael Wonder on 02 May 2024
Johnson & Johnson submits regulatory applications to EMA for Tremfya (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI ...
Posted by Michael Wonder on 02 May 2024
Neurocrine Biosciences announces US FDA approval of Ingrezza Sprinkle (valbenazine) capsules
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
Posted by Michael Wonder on 01 May 2024
Iterum Therapeutics resubmits new drug application to US FDA for oral sulopenem
29 April 2024 - Potential approval early Q4, 2024. ...
Posted by Michael Wonder on 01 May 2024
Bavarian Nordic initiates rolling submission of biologics license application with FDA for its Chikungunya vaccine candidate
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 01 May 2024
Eton Pharmaceuticals announces submission to FDA of new drug application for ET-400 (hydrocortisone oral solution)
30 April 2024 - Company anticipates 10 month review for potential approval in Q1, 2025. ...
Posted by Michael Wonder on 30 Apr 2024
Dermavant announces FDA acceptance of supplemental new drug application for Vtama (tapinarof) 1% cream for the treatment of atopic dermatitis in adults and children 2 years of age and older
29 April 2024 - FDA PDUFA action expected in Q4, 2024. ...
Posted by Michael Wonder on 25 Apr 2024
US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
Posted by Michael Wonder on 24 Apr 2024
Averoa submits marketing authorisation application to the European Medicines Agency seeking approval of AVA1014 for treating complications associated with chronic kidney disease
23 April 2024 - Averoa announces the submission of a marketing authorisation application to the EMA for Ferric Citrate Coordination ...
Posted by Michael Wonder on 23 Apr 2024
FDA approves lutetium Lu 177 dotatate for paediatric patients 12 years and older with GEP-NETs
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...