Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 21 Sep 2025
KalVista Pharmaceuticals announces European Commission and Swissmedic approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
19 September 2025 - First European launch of Ekterly expected in Germany Q4, 2025. ...
Posted by Michael Wonder on 21 Sep 2025
Idorsia’s Jeraygo (aprocitentan) approved in Switzerland for the treatment of resistant hypertension
19 September 2025 - Jeraygo is a new oral antihypertensive therapy – the first systemic hypertension treatment to target a new ...
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 21 Sep 2025
First treatment recommended for rare immunoglobulin-related autoimmune disease
19 September 2025 - Uplizna significantly reduced the number of flares in patients with active immunoglobulin G4-related disease. ...
Posted by Michael Wonder on 20 Sep 2025
Merck receives two positive EU CHMP opinions for Keytruda (pembrolizumab), for subcutaneous administration and for new indication for earlier-stage head and neck cancer
19 September 2025 - Positive opinion also granted for Keytruda as part of a peri-operative regimen for the treatment of certain ...
Posted by Michael Wonder on 20 Sep 2025
Elinzanetant recommended for approval in EU as treatment of moderate to severe vasomotor symptoms
19 September 2025 - Positive opinion by the CHMP is based on the results from the clinical development Phase 3 studies ...
Posted by Michael Wonder on 20 Sep 2025
CHMP recommends EU approval of Roche’s subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma
19 September 2025 - Subcutaneous Lunsumio has potential to substantially reduce treatment administration time with an approximately one minute injection, compared ...