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 23 May 2022
ATAGI update following weekly COVID-19 meeting (18 May 2022)
23 May 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 18 ...
Posted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...
Posted by Michael Wonder on 23 May 2022
NICE recommends offering app-based treatment for people with insomnia instead of sleeping pills
20 May 2022 - Hundreds of thousands of people suffering from insomnia who would usually be prescribed sleeping pills could be ...
Posted by Michael Wonder on 23 May 2022
CHMP recommends European Commission approval of upadacitinib (Rinvoq) for the treatment of adults with moderate to severe ulcerative colitis
23 May 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 23 May 2022
Vaxzevria approved in the EU as third dose booster against COVID-19
23 May 2022 - Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU approved ...
Posted by Michael Wonder on 22 May 2022
Patients deserve immediate access to FDA approved innovations — not bureaucratic restrictions
21 May 2022 - Innovation is the lifeblood that has made America the most economically successful nation in the modern era. ...
Posted by Michael Wonder on 22 May 2022
‘It’s scary, the thought of not having access’: new anti-depressant considered for PBS
22 May 2022 - A drug described as a last option for people with treatment-resistant depression, which psychiatrists say is ...
Posted by Michael Wonder on 21 May 2022
Bonesupport receives market authorisation for Cerement G in the US
18 May 2022 - BoneSupport today announced that the company has received market authorisation from the U.S. FDA, for the ...
Posted by Michael Wonder on 21 May 2022
PTC Therapeutics receives positive CHMP opinion for Upstaza for the treatment of AADC deficiency
20 May 2022 - First ever gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 21 May 2022
FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukaemia
20 May 2022 - Today the FDA approved azacitidine (Vidaza, Celgene) for paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia. ...
Posted by Michael Wonder on 21 May 2022
People dying of COVID while life-saving drugs go unused, doctors say
21 May 2022 - Top doctors have warned that vulnerable patients who test positive to COVID-19 are missing out on ...
Posted by Michael Wonder on 21 May 2022
CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD
20 May 2022 - Recommendation based on positive results from two clinical trials in which Xenpozyme provided improvement across multiple non-CNS ...
Posted by Michael Wonder on 21 May 2022
Karyopharm and Menarini Group receive positive CHMP opinion for Nexpovio (selinexor) for the treatment of patients with refractory multiple myeloma
20 May 2022 - European Commission decision anticipated within approximately 60 days. ...
Posted by Michael Wonder on 20 May 2022
Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions
20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...
Posted by Michael Wonder on 20 May 2022
FDA approves first treatment for eosinophilic esophagitis, a chronic immune disorder
20 May 2022 - Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis in adults and ...