Blog
RSS FeedPosted 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 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 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
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 ...
Posted by Michael Wonder on 23 Sep 2025
Idebenone accepted by FDA for priority review for Leber hereditary optic neuropathy
22 September 2025 - Chiesi Global Rare Diseases today announced the US FDA is evaluating the regulatory submission of idebenone to ...
Posted by Michael Wonder on 22 Sep 2025
Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis
22 September 2025 - The US FDA has extended by three months the target action date of its review of the ...
Posted by Michael Wonder on 22 Sep 2025
Tremfya (guselkumab) achieves US approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen
19 September 2025 - Johnson & Johnson is initiating a head to head study seeking to demonstrate the superiority of Tremfya ...
Posted by Michael Wonder on 21 Sep 2025
Otsuka and Lundbeck receive complete response letter from US FDA for sNDA of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder
20 September 2025 - Otsuka and Lundbeck) announce that Otsuka has received a Complete Response Letter from the US FDA regarding ...
Posted by Michael Wonder on 19 Sep 2025
FDA grants accelerated approval to first treatment for Barth syndrome
19 September 2025 - New treatment for Barth syndrome showcases FDA’s commitment to bringing effective and safe medications to patients in ...