Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 20 Sep 2022
AvroBio receives rare paediatric disease designation from US FDA for first gene therapy in development for cystinosis
20 September 2022 - AVR-RD-04 has previously received orphan drug designation from FDA and EMA. ...
Posted by Michael Wonder on 20 Sep 2022
EMA accepts MediWound’s application for extended indication for NexoBrid to treat paediatric patients with severe thermal burns
20 September 2022 - Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for ...
Posted by Michael Wonder on 20 Sep 2022
Aurinia announces European Commission approval of Lupkynis (voclosporin) for the treatment of lupus nephritis
19 September 2022 - Lupkynis is the first oral medicine approved in both the US and Europe for the treatment of ...
Posted by Michael Wonder on 20 Sep 2022
Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
20 September 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
Posted by Michael Wonder on 20 Sep 2022
NICE recommends BeiGene’s Brukinsa (zanubrutinib) for patients with Waldenström’s macroglobulinaemia who have had at least one treatment
19 September 2022 - Brukinsa Is the first Bruton’s tyrosine kinase inhibitor recommended by NICE for routine use for Waldenström’s macroglobulinaemia. ...
Posted by Michael Wonder on 20 Sep 2022
European Medicine Agency accepts marketing authorisation applications for bimekizumab in psoriatic arthritis and axial spondyloarthritis
20 September 2022 - First regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide. ...
Posted by Michael Wonder on 19 Sep 2022
Pharmacists can now prescribe Paxlovid, but barriers persist
19 September 2022 - Recently, the FDA expanded access to COVID-19 treatment by authorising state-licensed pharmacists to prescribe Paxlovid to eligible ...
Posted by Michael Wonder on 19 Sep 2022
European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
19 September 2022 - Phase 3 data that showed people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema treated with ...
Posted by Michael Wonder on 19 Sep 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
19 September 2022 - If approved, Brukinsa will be the first and only approved Bruton’s tyrosine kinase inhibitor for marginal zone ...
Posted by Michael Wonder on 19 Sep 2022
Bristol Myers Squibb receives European Commission approval for LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab), for the treatment of unresectable or metastatic melanoma with tumour cell PD-L1 expression < 1%
16 September 2022 - In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy. ...
Posted by Michael Wonder on 19 Sep 2022
Biosimilar medicines can be interchanged
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
Posted by Michael Wonder on 19 Sep 2022
Seagen announces Tukysa (tucatinib) in combination with trastuzumab granted priority review by FDA for previously treated HER2 positive metastatic colorectal cancer
19 September 2022 - FDA has set action date of 19 January 2023 . ...
Posted by Michael Wonder on 19 Sep 2022
FDA grants Radiopharm Theranostics DUNP19 product rare paediatric disease designation
16 September 2022 - Radiopharm Theranostics has been granted rare paediatric disease designation by the US FDA for its DUNP19 ...
Posted by Michael Wonder on 19 Sep 2022
AbbVie secures positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderate to severe Crohn's disease
19 September 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 19 Sep 2022
Registry-based randomised trials: the best of both worlds?
15 September 2022 - IQWiG authors present the advantages and disadvantages of study designs that combine explanatory and pragmatic aspects. ...