Blog
RSS FeedPosted 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 24 Sep 2025
Teva and Medincell’s risperidone LAI approved in Canada as Longavo
23 September 2025 - Teva Canada has received regulatory approval for risperidone long-acting injection from Health Canada for the treatment ...
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
EMA recommends marketing authorisation of AVT03, Alvotech’s proposed biosimilar to Prolia and Xgeva
22 September 2025 - Alvotech today announced that the EMA's CHMP has adopted a positive opinion recommending approval for AVT03, Alvotech’s ...
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 23 Sep 2025
European Commission approves Servier's Voranigo (vorasidenib) as the first targeted therapy for grade 2 IDH mutant glioma in the EU
22 September 2025 - Voranigo demonstrated significant improvement in progression-free survival with a favourable safety profile in a pivotal Phase ...
Posted by Michael Wonder on 23 Sep 2025
FDA takes action to make a treatment available for autism symptoms
22 September 2025 - The US FDA today initiated the approval of leucovorin calcium tablets for patients with cerebral folate ...
Posted by Michael Wonder on 23 Sep 2025
MavriX Bio receives FDA fast track designation for MVX-220 for treatment of Angelman syndrome
22 September 2025 - MavriX Bio today announced that the US FDA has granted fast track designation for MVX-220, an investigational ...
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
Koselugo recommended for approval in the EU by CHMP for plexiform neurofibromas in adults with neurofibromatosis type 1
22 September 2025 - Recommendation based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 22 Sep 2025
Tezspire recommended for approval in the EU by CHMP for chronic rhinosinusitis with nasal polyps
22 September 2025 - Recommendation based on WAYPOINT Phase III trial results showing Tezspire reduced nasal polyp severity and nasal ...
Posted by Michael Wonder on 22 Sep 2025
Dupixent (dupilumab) to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion
22 September 2025 - Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives ...
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 ...