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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 24 Jan 2022
Cook Medical receives FDA breakthrough designation for new drug eluting stent
21 January 2022 - Cook Medical has received breakthrough device designation from the US FDA on a new drug eluting stent ...
Posted by Michael Wonder on 24 Jan 2022
Codexis announces FDA orphan drug and rare paediatric disease designations for CDX-6512 for the treatment of homocystinuria
24 January 2022 - Codexis today announced that the U.S. FDA has granted the company orphan drug designation for CDX-6512 for ...
Posted by Michael Wonder on 24 Jan 2022
Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva
24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...
Posted by Michael Wonder on 24 Jan 2022
Merck provides US and Japan regulatory update for gefapixant
24 January 2022 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 24 Jan 2022
People with chronic myeloid leukaemia granted early access to Novartis’ investigational treatment
24 January 2022 - The Medicine and Healthcare products Regulatory Agency grants positive scientific opinion on use of asciminib as 3rd-line ...
Posted by Michael Wonder on 24 Jan 2022
EMA publishes agenda for 24-27 Jan CHMP meeting
23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 Jan 2022
Chugai’s Actemra approved for additional indication of SARS-CoV-2 pneumonia in Japan
21 January 2022 - The approval is based on the results of several clinical studies in hospitalised patients with COVID-19. ...
Posted by Michael Wonder on 24 Jan 2022
TGA approves MSD's Vaxneuvance
24 January 2022 - Vaxneuvance (pneumococcal 15 valent conjugate vaccine (CRM197 protein)) was approved on 17 January 2022 for active ...
Posted by Michael Wonder on 24 Jan 2022
Novavax COVID-19 vaccine to be available in coming weeks
24 January 2022 - Australians aged 18+ will now have access to a fourth COVID-19 vaccine, Nuvaxovid (Novavax) in coming weeks, ...
Posted by Michael Wonder on 24 Jan 2022
FDA considers limiting authorisation of certain monoclonal antibody treatments
23 January 2022 - Federal regulators are considering limiting the authorisation of certain monoclonal antibody treatments that have not proved ...
Posted by Michael Wonder on 24 Jan 2022
Patients to receive new cancer drugs faster under Brexit rules shake-up
23 January 2022 - Seven medicines already approved as changes cut as much as a month off approval times. ...
Posted by Michael Wonder on 24 Jan 2022
Australians with severe dermatitis to benefit from PBS listing
24 January 2022 - From 1 February 2022, Australians with severe atopic dermatitis will have access to a new treatment ...
Posted by Michael Wonder on 23 Jan 2022
ATAGI statement on the use of Novavax COVID-19 vaccine (Nuvaxovid)
24 January 2022 - ATAGI recommends that Novavax COVID-19 vaccine can be used for the primary course of COVID-19 vaccination ...
Posted by Michael Wonder on 23 Jan 2022
Pharmacists struggle to meet demand for free COVID test kits amid stock shortage
23 January 2022 - Chemists across the country say they do not have enough rapid antigen tests to start handing ...
Posted by Michael Wonder on 23 Jan 2022
Thousands to benefit from decision to subsidise eczema treatment
23 January 2022 - Australians suffering from a severe form of eczema will save tens of thousands of dollars after a ...