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 28 Mar 2022
U.S. FDA approves Fintempla (fenfluramine) oral solution for treatment of seizures associated with Lennox-Gastaut syndrome
28 March 2022 - Approval based on data where fenfluramine demonstrated efficacy in the most difficult to treat seizure types, including ...
Posted by Michael Wonder on 28 Mar 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives European Commission approval for the treatment of adults with advanced systemic mastocytosis
25 March 2022 - Initial commercial launch is planned for Germany immediately following the European Commission approval. ...
Posted by Michael Wonder on 28 Mar 2022
Atidarsagene autotemcel for treating metachromatic leukodystrophy
28 March 2022 - NICE has published evidence-based recommendations on atidarsagene autotemcel (Libmeldy) for treating metachromatic leukodystrophy in children. ...
Posted by Michael Wonder on 28 Mar 2022
Xenpozyme (olipudase alfa) approved in Japan, first and only approved therapy indicated to treat acid sphingomyelinase deficiency
28 March 2022 - Xenpozyme represents first Sanofi therapy to be approved under the SAKIGAKE ‘fast-track’ designation. ...
Posted by Michael Wonder on 28 Mar 2022
China approves Takeda cancer drug
25 March 2022 - Japanese pharmaceutical company Takeda announced on Friday that brigatinib, an innovative lung cancer drug, has been approved ...
Posted by Michael Wonder on 28 Mar 2022
Health Canada grants marketing authorisation for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene
25 March 2022 - CNW/ - Vertex Pharmaceuticals Canada today announced that Health Canada has granted marketing authorisation for the ...
Posted by Michael Wonder on 28 Mar 2022
Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis of COVID-19 in a broad population
28 March 2022 - Evusheld retains neutralising activity against the Omicron BA.2 subvariant, now the dominant strain in Europe ...
Posted by Michael Wonder on 28 Mar 2022
ATAGI update following weekly COVID-19 meeting (23 March 2022)
28 March 2022 - ATAGI have provided recommendations on a winter booster dose of COVID-19 vaccine to increase vaccine protection ...
Posted by Michael Wonder on 28 Mar 2022
2022 seasonal influenza vaccines
25 March 2022 - The Australian Influenza Vaccine Committee has reviewed data related to epidemiology, antigenic and genetic characteristics of recent ...
Posted by Michael Wonder on 28 Mar 2022
Japan's Ministry of Health, Labour and Welfare accepts Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
25 March 2022 - Bristol-Myers Squibb today announced that the MHLW has accepted the supplemental new drug application for Breyanzi ...
Posted by Michael Wonder on 28 Mar 2022
Federal Budget vision must extend beyond election day to secure better long-term health for all Australians
28 March 2022 - Medicines Australia is hoping tomorrow’s Budget reveals a long-term vision for health with strong investments in ...
Posted by Michael Wonder on 26 Mar 2022
Landmark PBS listing for Australians with cystic fibrosis
27 March 2022 - From April 1 2022, Trikafta (elexacaftor with tezacaftor and ivacaftor and ivacaftor) will be available on ...
Posted by Michael Wonder on 25 Mar 2022
Bristol Myers Squibb announces new Prescription Drug User Fee Act goal date for Reblozyl (luspatercept-aamt) supplemental biologics license application
25 March 2022 - Bristol Myers Squibb today announced that the U.S. FDA has extended the review of the supplemental ...
Posted by Michael Wonder on 25 Mar 2022
Highlights from the CHMP 21-24 March 2022 meeting
25 March 2022 - The EMA’s CHMP recommended five medicines for approval at its March 2022 meeting. ...
Posted by Michael Wonder on 25 Mar 2022
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) for patients with microsatellite instability-high or mismatch repair deficient tumours in five different types of cancer
25 March 2022 - Recommendation supports use of Keytruda for certain patients with unresectable or metastatic MSI-H/dMMR colorectal, gastric, small ...