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 19 Jun 2022
Start of rolling review for adapted Spikevax COVID-19 vaccine
17 June 2022 - EMA has started a rolling review for a version of Spikevax adapted to provide better protection ...
Posted by Michael Wonder on 18 Jun 2022
Moderna receives FDA authorisation for emergency use of its COVID-19 vaccine for children 6 months of age and older
17 June 2022 - mRNA-1273 has been administered to millions of children and adolescents over the age of 6 worldwide, ...
Posted by Michael Wonder on 18 Jun 2022
Pfizer-BioNTech COVID-19 vaccine receives FDA emergency use authorisation for children 6 months through 4 years of age
17 June 2022 - In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this ...
Posted by Michael Wonder on 17 Jun 2022
Sierra Oncology announces submission of new drug application for momelotinib to US Food & Drug Administration
17 June 2022 - Submission seeks approval of momelotinib for the treatment of myelofibrosis. ...
Posted by Michael Wonder on 17 Jun 2022
NICE recommends new targeted treatment for early breast cancer
16 June 2022 - NICE has provisionally approved a new treatment for early breast cancer that it says will benefit ...
Posted by Michael Wonder on 17 Jun 2022
Skyrizi (risankizumab-rzaa) receives FDA approval as the first and only specific interleukin-23 to treat moderately to severely active Crohn's disease in adults
17 June 2022 - Third approved indication for risankizumab-rzaa is supported by safety and efficacy data from two induction and one ...
Posted by Michael Wonder on 17 Jun 2022
Outcomes of the May 2022 PBAC intracycle meeting
17 June 2022 - The outcomes from the May 2022 PBAC meeting are now available. ...
Posted by Michael Wonder on 17 Jun 2022
Public consultation: draft 2022-23 cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
17 June 2022 - Consultation on the content of the draft 2022-23 Cost Recovery Implementation Statement (CRIS) for listing medicines ...
Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
Posted by Michael Wonder on 16 Jun 2022
COVID-19 vaccine weekly safety report (16 June 2022)
16 June 2022 - To 12 June 2022, the TGA has received 584 reports which have been assessed as likely to ...
Posted by Michael Wonder on 16 Jun 2022
Core network partners announced for CADTH’s post-market drug evaluation network
10 June 2022 - CADTH is pleased to announce the four successful core network partners of its inaugural post-market drug ...
Posted by Michael Wonder on 16 Jun 2022
NHS lands breakthrough in global battle against superbugs
15 June 2022 - The NHS is set to roll out two ‘superbug’ busting drugs through a world first, pioneering ...
Posted by Michael Wonder on 16 Jun 2022
MHRA joins international partnerships to set global standards for medicines and medical devices regulation
16 June 2022 - These are the International Medical Device Regulatory Forum, the International Council for Harmonisation of Technical Requirements for ...
Posted by Michael Wonder on 16 Jun 2022
Savara awarded innovation passport in United Kingdom for molgramostim nebuliser solution, a novel investigational inhaled biologic
16 June 2022 - Innovation passport awarded to molgramostim for the treatment of auto-immune pulmonary alveolar proteinosis, a rare lung disease. ...
Posted by Michael Wonder on 16 Jun 2022
Subsidy for medicine for Duchenne muscular dystrophy expires
16 June 2022 - The TLV has decided that Translarna, which is subsidised for patients with Duchenne muscular dystrophy, will not ...