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RSS FeedPosted by Michael Wonder on 30 Sep 2025
FDA approves Guardant360 CDx as companion diagnostic for Eli Lilly and Company’s Inluriyo (imlunestrant) for treatment of ESR1 mutated advanced breast cancer
29 September 2025 - This marks the second FDA approved indication for Guardant360 CDx as a companion diagnostic in breast cancer ...
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 ...
Posted by Michael Wonder on 26 Sep 2025
Vertex announces key advancements across kidney portfolio
25 September 2025 - Vertex announced today that the FDA has granted breakthrough therapy designation to povetacicept for the treatment of ...
Posted by Michael Wonder on 25 Sep 2025
FDA approves imlunestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
25 September 2025 - Today, the FDA approved imlunestrant (Inluriyo, Eli Lilly), an oestrogen receptor antagonist, for adults with oestrogen ...
Posted by Michael Wonder on 25 Sep 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
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 ...
Posted by Michael Wonder on 24 Sep 2025
Enhertu plus pertuzumab granted priority review in the US as first-line treatment for patients with HER2 positive metastatic breast cancer
24 September 2025 - Based on DESTINY-Breast09 Phase 3 trial results, which showed Enhertu plus pertuzumab reduced the risk of ...
Posted by Michael Wonder on 24 Sep 2025
FDA use of real world evidence in regulatory decision-making
22 September 2025 - The FDA has a long history of using real world data and real-world evidence to monitor and ...
Posted by Michael Wonder on 23 Sep 2025
Sanofi’s SAR446268 earns US fast track designation for the treatment of non-congenital myotonic dystrophy type 1
23 September 2025 - Designation earned for one time AAV gene therapy SAR446268, designed to silence DMPK expression. ...
Posted by Michael Wonder on 23 Sep 2025
FDA issues complete response letter for apitegromab as a treatment for patients with spinal muscular atrophy
23 September 2025 - No other approvability issues cited in complete response letter. ...
Posted by Michael Wonder on 23 Sep 2025
Lexicon Pharmaceuticals announces update on submission of additional data to US FDA supporting the benefit-risk profile of Zynquista in type 1 diabetes
23 September 2025 - Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December ...