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RSS FeedPosted by Michael Wonder on 16 Oct 2025
Rocket Pharmaceuticals announces FDA acceptance of BLA resubmission of Kresladi for the treatment of severe leukocyte adhesion deficiency-I
14 October 2025 - PDUFA target action date is 28 March 2026. ...
Posted by Michael Wonder on 14 Oct 2025
MannKind announces US FDA accepts for review its supplemental biologics license application for inhaled ansulin (Afrezza) in children and adolescents aged 4-17 years living with diabetes
13 October 2025 - MannKind Corporation today announced that the US FDA has accepted the supplemental biologics license application seeking approval ...
Posted by Michael Wonder on 13 Oct 2025
Denali Therapeutics announces FDA review extension of BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome)
13 October 2025 - Denali Therapeutics today announced that the US FDA has extended its review timeline of the biologics license ...
Posted by Michael Wonder on 08 Oct 2025
Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval
8 October 2025 - Xspray Pharma has received a complete response letter from the US FDA concerning the Company’s new ...
Posted by Michael Wonder on 08 Oct 2025
US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis
7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...
Posted by Michael Wonder on 07 Oct 2025
Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies
6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...
Posted by Michael Wonder on 02 Oct 2025
Wockhardt submits new drug application to US FDA for zidebactam-cefepime (WCK 5222) for treatment of serious gram-negative infections
1 October 2025 - Wockhardt today announced the submission of new drug application to the US FDA for its novel ...
Posted by Michael Wonder on 02 Oct 2025
TAHO Pharma announces submission of new drug application to the US FDA for TAH3311 – the world’s first apixaban oral dissolving film – represents a transformational advancement in anti-coagulant therapy
30 September 2025 - TAHO Pharmaceuticals today announced the submission of its new drug application to the US FDA for TAH3311, ...
Posted by Michael Wonder on 02 Oct 2025
Pharming Group announces US FDA acceptance and priority review of supplemental new drug application for leniolisib in children with APDS aged 4 to 11 years
1 October 2025 - Pharming today announced that the US FDA has accepted its supplemental new drug application seeking approval for ...
Posted by Michael Wonder on 01 Oct 2025
Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery
1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo ...
Posted by Michael Wonder on 01 Oct 2025
Disc Medicine announces submission of new drug application to US FDA for accelerated approval of bitopertin for patients with erythropoietic protoporphyria
30 September 2025 - Disc is seeking accelerated approval and priority review of its new drug application submission. ...
Posted by Michael Wonder on 01 Oct 2025
Novo Nordisk resubmits Awiqli to the FDA with potential to be the first once weekly basal insulin treatment for adults with type 2 diabetes
29 September 2025 - Awiqli (insulin icodec) injection, if approved, has the potential to be the first once weekly basal insulin ...
Posted by Michael Wonder on 30 Sep 2025
AbbVie submits biologics license application to US FDA for pivekimab sunirine - an investigational antibody-drug conjugate to treat rare cancer with limited treatment options
30 September 2025 - Biologics license application based on data from the global Phase 1/2 CADENZA trial. ...
Posted by Michael Wonder on 26 Sep 2025
AbbVie submits new drug application to US FDA for tavapadon for the treatment of Parkinson's fisease
26 September 2025 - Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's ...
Posted by Michael Wonder on 24 Sep 2025
Biogen provides regulatory update on high dose regimen of nusinersen
23 September 2023 - Biogen today announced that the US FDA issued a complete response letter for the Company’s supplemental ...