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 12 Feb 2026
99mTc-maraciclatide granted FDA fast track designation for the visualisation of inflammation in interstitial lung disease
12 February 2026 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as ...
Posted by Michael Wonder on 12 Feb 2026
FDA approves labelling changes to menopausal hormone therapy products
12 February 2026 - The US FDA has approved drug labelling changes to six menopausal hormone therapy products, also known as ...
Posted by Michael Wonder on 12 Feb 2026
ICER publishes final evidence report on medication for smoking cessation
12 February 2026 - Independent appraisal committee votes reflect a net health benefit for cytisinicline alone, but uncertainty when compared ...
Posted by Michael Wonder on 12 Feb 2026
FDA refusing to review Moderna mRNA flu shot application
11 February 2026 - Moderna said on Tuesday that the FDA has refused to review its application for an mRNA flu ...
Posted by Michael Wonder on 12 Feb 2026
Datroway supplemental new drug application submitted in Japan for patients with metastatic triple negative breast cancer Who Are Not Candidates for Immunotherapy
12 February 2026 - Based on results from TROPION-Breast02 showing Datroway significantly improved overall survival versus chemotherapy in this patient ...
Posted by Michael Wonder on 12 Feb 2026
PHARMAC seeking feedback on plans to modernise the Pharmaceutical Schedule
12 February 2026 - PHARMAC has begun work to update the Pharmaceutical Schedule to make it easier to use, faster ...
Posted by Michael Wonder on 12 Feb 2026
Pharma group warns drug price cuts threaten industry investment
10 February 2026 - KPBMA demands postponement, impact assessments, and policy dialogue to protect R&D and health security amid pricing reforms. ...
Posted by Michael Wonder on 12 Feb 2026
Price, therapeutic value impact international submission times for new drugs
11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...
Posted by Michael Wonder on 12 Feb 2026
BioMarin receives Health Canada Notice of Compliance with conditions for Voxzogo for achondroplasia
11 February 2026 - BioMarin has today announced Health Canada has granted a Notice of Compliance with Conditions for Voxzogo ...
Posted by Michael Wonder on 12 Feb 2026
Agenda for the March 2026 PBAC meeting (12 February 2026)
12 February 2026 - The Department of Health has published an updated agenda for the March 2026 PBAC agenda (version 5). ...
Posted by Michael Wonder on 12 Feb 2026
Lifesaving drugs blocked by Australia’s ‘broken’ approvals process
12 February 2026 - Australia’s processes for funding vital medicines is recognised as broken. Lives are on the line as patients, ...
Posted by Michael Wonder on 12 Feb 2026
Sick Australians risk being locked out of lifesaving medicines by outdated PBS
12 February 2026 - More medicines are successfully treating illness and disease, but Pfizer’s local boss says the PBS is falling ...
Posted by Michael Wonder on 11 Feb 2026
PHARMAC confirms changes to simplify biologic medicine funding criteria
11 February 2026 - PHARMAC has confirmed changes to the Special Authority and Hospital Indication Restrictions criteria for four biologic ...
Posted by Michael Wonder on 11 Feb 2026
Moderna receives refusal to file letter from the US FDA for its investigational seasonal influenza vaccine, mRNA-1010
10 February 2026 - Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
Posted by Michael Wonder on 11 Feb 2026
Canadians wait, on average, more than 65 weeks longer for access to new medicines than Europeans and 90 weeks more than Americans
10 February 2025 - Canadian patients are waiting, on average, more than 65 weeks longer than Europeans and over 90 ...