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RSS FeedPosted 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
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
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 04 Oct 2025
FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
3 October 2025 - Regimen recommended in National Comprehensive Cancer Network Guidelines for small cell lung cancer. ...
Posted by Michael Wonder on 03 Oct 2025
FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer
2 October 2025 - Today, the FDA approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq) or atezolizumab and ...
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 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 30 Sep 2025
Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria
30 September 2025 - Remibrutinib also in clinical development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa, expanding Novartis Immunology ...
Posted by Michael Wonder on 30 Sep 2025
Kedrion Biopharma receives FDA approval for Qivigy (immune globulin 10% IV) for treatment of primary humoral immunodeficiency in Adults
29 September 2025 - Kedrion Biopharma announced today that it has received FDA approval for Qivigy immune globulin intravenous (human)-kthm 10% ...
Posted by Michael Wonder on 30 Sep 2025
US FDA approves Tremfya (guselkumab) for the treatment of paediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor
29 September 2025 - Approval was based on PROTOSTAR study, which showed paediatric patients receiving Tremfya achieved high levels of ...
Posted by Michael Wonder on 26 Sep 2025
Crinetics announces FDA approval of Palsonify (paltusotine) for the treatment of adults with acromegaly
25 September 2025 - Approval based on data from two pivotal Phase 3 trials where Palsonify was well tolerated and resulted ...
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 26 Sep 2025
Evkeeza (evinacumab-dgnb) ANGPTL3 antibody approved in the US for children as young as 1 year old with ultra-rare form of high cholesterol
26 September 2025 - Regeneron Pharmaceuticals today announced that the US FDA has approved Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct ...