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 Apr 2022
U.S. Food and Drug Administration approves Camzyos (mavacamten) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms
28 April 2022 - Camzyos is the first and only FDA approved cardiac myosin inhibitor that specifically targets the source of ...
Posted by Michael Wonder on 29 Apr 2022
Timber Pharmaceuticals announces fast track designation granted by FDA for TMB-001 in severe subtypes of congenital ichthyosis
28 April 2022 - Company expects to launch pivotal Phase 3 ASCEND clinical trial to evaluate TMB-001 within the next ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 28 Apr 2022
Janssen submits marketing authorisation application to EMA seeking approval of niraparib and abiraterone acetate dual action tablet plus prednisone for the treatment of patients with HRR gene mutated metastatic castration resistant prostate cancer
28 April 2022 - The submission to the EMA is based on results from the Phase 3 MAGNITUDE study evaluating niraparib ...
Posted by Michael Wonder on 28 Apr 2022
Insights from the March 2022 PBAC meeting (part 3)
29 April 2022 - Wegovy was the first discrete medicine to have a stakeholder meeting before its consideration by the ...
Posted by Michael Wonder on 28 Apr 2022
COVID-19 vaccine weekly safety report (28 April 2022)
28 April 2022 - To 24 April 2022, the TGA has received 544 reports which have been assessed as likely to ...
Posted by Michael Wonder on 28 Apr 2022
Market for new medicines in Canada has not slowed over last two years, despite focus on COVID-19 treatments
28 April 2022 - An average of nine new medicines per quarter have been approved in Canada through the pandemic, ...
Posted by Michael Wonder on 28 Apr 2022
FDA approves Mycovia Pharmaceuticals’ Vivjoa (oteseconazole), the first and only FDA approved medication for recurrent vulvovaginal candidiasis
28 April 2022 - U.S. commercial launch of Vivjoa expected in Q2, ...
Posted by Michael Wonder on 28 Apr 2022
Cancer agency report duplicates PHARMAC role
28 April 2022 - The Cancer Control Agency’s analysis of the gap between Australia and New Zealand in funding 18 selected ...
Posted by Michael Wonder on 28 Apr 2022
TGA grants provisional determination for the Moderna bivalent COVID-19 vaccine "Spikevax Bivalent Zero/Omicron"
28 April 2022 - On 27 April 2022, the TGA granted a provisional determination to Moderna in relation to its ...
Posted by Michael Wonder on 28 Apr 2022
Access criteria for antiviral treatments widened as molnupiravir arrives in New Zealand
28 April 2022 - PHARMAC is widening access to the antivirals to treat people with early COVID-19, after receiving feedback from ...
Posted by Michael Wonder on 28 Apr 2022
Ultomiris approved in the US for adults with generalised myasthenia gravis
28 April 2022 - First and only long-acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised myasthenia gravis. ...
Posted by Michael Wonder on 28 Apr 2022
FDA grants BTX 1801 new qualified infectious disease product designation status
28 April 2022 - With the recent completion of additional animal studies, the Phase 2 clinical study for BTX 1801 ...
Posted by Michael Wonder on 28 Apr 2022
Baqsimi (nasal glucagon), rescue treatment for severe hypoglycaemia now covered in British Colombia, Alberta & Saskatchewan
27 April 2022 - Lilly Canada is pleased to announce that as of 5 April 2022, Baqsimi (glucagon nasal powder) ...
Posted by Michael Wonder on 28 Apr 2022
Nocira becomes first company ever to announce breakthrough device designation by the FDA for acute treatment of migraine
27 April 2022 - Nocira's hand held device that uses gentle, controlled puffs of air in the ears for treating migraine ...