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 29 Jan 2024
Rezzayo approved to treat adult patients with invasive candidiasis
29 January 2024 - The MHRA has today approved the medicine Rezzayo (rezafungin) to treat a fungal infection called invasive candidiasis. ...
Posted by Michael Wonder on 29 Jan 2024
Celltrion USA completes submission of biologics license application for CT-P47, a biosimilar candidate of Actemra (tocilizumab)
28 January 2024 - The biologics license application for CT-P47 was based on Phase III data comparing CT-P47 to the ...
Posted by Michael Wonder on 29 Jan 2024
Commemorating 40 years of Medicare
29 January 2024 - The Australian Government is releasing a special edition Medicare card in 2024 to commemorate the 40th anniversary ...
Posted by Michael Wonder on 29 Jan 2024
Enhertu granted priority review in the US for patients with metastatic HER2 positive solid tumours
29 January 2024 - Application based on results from DESTINY-PanTumor02 trial and supported by additional Enhertu data. ...
Posted by Michael Wonder on 29 Jan 2024
Updates to the HTA Review: options paper for Consultation 2 published
25 January 2024 - The Options paper for Consultation 2 is now available on the Office of Health Technology Assessment consultation ...
Posted by Michael Wonder on 27 Jan 2024
ICER publishes evidence report on treatment for schizophrenia
25 January 2024 - KarXT has a novel mechanism of action, but there are significant uncertainties regarding long term efficacy ...
Posted by Michael Wonder on 27 Jan 2024
Highlights from the 22-25 January 2024 CHMP meeting
26 January 2024 - The EMA’s CHMP recommended three medicines for approval at its January 2024 meeting. ...
Posted by Michael Wonder on 26 Jan 2024
Four dose Mounjaro “KwikPen” approved by MHRA for diabetes and weight management
25 January 2024 - The new presentation of Mounjaro gives four doses for once a week treatment over a month. ...
Posted by Michael Wonder on 26 Jan 2024
Outcomes from the December 2023 PBAC intracycle meeting
25 January 2024 - The outcomes from the December 2023 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 26 Jan 2024
Liquidia provides update on new drug application for Yutrepia (treprostinil) inhalation powder
25 January 2024 - Liquidia announced today that the US FDA provided an update on its review of the new drug ...
Posted by Michael Wonder on 26 Jan 2024
Dupixent (dupilumab) FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic oesophagitis
25 January 2024 - Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved ...
Posted by Michael Wonder on 26 Jan 2024
Bristol Myers Squibb receives positive CHMP opinion for CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple class exposed relapsed and refractory multiple myeloma
26 January 2024 - Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, ...
Posted by Michael Wonder on 26 Jan 2024
CHMP issues negative opinion for renewal of conditional marketing authorisation for Translarna (ataluren) following re-examination procedure
25 January 2024 - PTC Therapeutics announced today that the CHMP of the EMA issued a negative opinion following the re-examination ...
Posted by Michael Wonder on 26 Jan 2024
Theratechnologies receives complete response letter from the FDA for the F8 formulation of tesamorelin sBLA
24 January 2024 - FDA requesting clarifications around chemistry, manufacturing and controls and additional information related to immunogenicity. ...
Posted by Michael Wonder on 26 Jan 2024
European Medicines Agency validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival. ...