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 30 Sep 2022
TGA grants provisional determination to Moderna’s COVID-19 bivalent (Original plus Omicron BA.4/BA.5) booster dose vaccine
30 September 2022 - On 28 September 2022, the TGA granted a provisional determination to Moderna's bivalent COVID-19 vaccine candidate: elasomeran ...
Posted by Michael Wonder on 30 Sep 2022
European Medicines Agency accepts Astellas’ marketing authorisation application for fezolinetant
30 September 2022 - If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor ...
Posted by Michael Wonder on 29 Sep 2022
Why non-funding of cystic fibrosis treatment is unacceptable
30 September 2022 - Edward Lee has self-funded the Trikafta drug that alleviates the symptoms of his cystic fibrosis since 2019. ...
Posted by Michael Wonder on 29 Sep 2022
BioMarin resubmits biologics license application for valoctocogene roxaparvovec AAV gene therapy for severe haemophilia A to the FDA
29 September 2022 - BLA includes substantial body of data from pivotal Phase 3 and on-going Phase 1/2 studies. ...
Posted by Michael Wonder on 29 Sep 2022
FDA approves new treatment option for patients with ALS
29 September 2022 - The US FDA today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis, commonly ...
Posted by Michael Wonder on 29 Sep 2022
EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products
29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...
Posted by Michael Wonder on 29 Sep 2022
Catalyst Pharmaceuticals announces FDA approval of supplemental new drug application for Firdapse expanding patient population to include paediatric patients
29 September 2022 - Firdapse is now a treatment option for all LEMS patients 6 years of age and older in ...
Posted by Michael Wonder on 29 Sep 2022
MHRA appoints first new UK approved body to certify medical devices since Brexit
29 September 2022 - DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies. ...
Posted by Michael Wonder on 29 Sep 2022
Fore Biotherapeutics announces fast track designation granted by FDA to FORE8394 for the treatment of cancers harbouring BRAF class 1 and class 2 alterations
28 September 2022 - FORE8934 currently being evaluated in Phase 1/2a trial for the treatment of advanced solid and CNS tumours ...
Posted by Michael Wonder on 29 Sep 2022
TGA provisionally approves Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran) for use in children aged 6 months to less than 5 years
29 September 2022 - On 29 September 2022, the TGA provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, Comirnaty (tozinameran), ...
Posted by Michael Wonder on 29 Sep 2022
Europe's generic drugmakers say they may cut output due to energy bills
28 September 2022 - Europe's drugmakers have warned they may stop making some cheap generic medicines because of surging electricity ...
Posted by Michael Wonder on 29 Sep 2022
European Medicines Agency accepts Moderna's conditional marketing authorisation filing for its Omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine
28 September 2022 - Filing follows approval of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster vaccine targeting the Omicron BA.1 ...
Posted by Michael Wonder on 29 Sep 2022
Auckland toddler may be able to dance again after PHARMAC proposes funding drug
29 September 2022 - An Auckland toddler who was losing the ability to walk may be able to dance again, ...
Posted by Michael Wonder on 28 Sep 2022
Dupixent (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis
28 September 2022 - Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two ...
Posted by Michael Wonder on 28 Sep 2022
Citius Pharmaceuticals submits biologics license application to the US Food and Drug Administration for denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma
28 September 2022 - Citius Pharmaceuticals today announced that the Company has submitted a biologics license application to the US FDA ...