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 26 Jan 2021
Scott Morrison says Australia will not be a hostage to global vaccine shortages
26 January 2021 - Scott Morrison has revealed why Australia won’t be “completely hostage” to overseas vaccine schedules and shortages. ...
Posted by Michael Wonder on 26 Jan 2021
MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...
Posted by Michael Wonder on 26 Jan 2021
NICE publishes second appraisal consultation document for Zytiga
26 January 2021 - NICE has had another look at abiraterone acetate for the treatment of patients with newly diagnosed ...
Posted by Michael Wonder on 26 Jan 2021
Recordati Rare Diseases: Carbaglu (carglumic acid) receives U.S. FDA approval for a new indication to treat acute hyperammonaemia associated with propionic acidemia and methylmalonic acidemia
26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...
Posted by Michael Wonder on 26 Jan 2021
Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
Posted by Michael Wonder on 26 Jan 2021
Symbicort Turbuhaler approved in China as an anti-inflammatory reliever in mild asthma
26 January 2021 - Symbicort Turbuhaler becomes the first dual-combination therapy approved in China for mild, moderate and severe asthma ...
Posted by Michael Wonder on 26 Jan 2021
FDA approves Theranica's Nerivio for acute treatment of migraine in adolescents
25 January 2021 - Theranica today announced that its Nerivio therapeutic device has received the FDA clearance to market for ...
Posted by Michael Wonder on 26 Jan 2021
Albireo announces U.S. FDA acceptance of new drug application for odevixibat
25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...
Posted by Michael Wonder on 26 Jan 2021
Iterum Therapeutics announces U.S. FDA filing acceptance of new drug application for oral sulopenem
25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...
Posted by Michael Wonder on 25 Jan 2021
AstraZeneca is finding it hard to keep its COVID-19 vaccine promises
26 January 2021 - As countries scramble to inoculate their populations against COVID-19, the vaccine developed by AstraZeneca and the ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves AbbVie's Rinvoq (upadacitinib) for the treatment of psoriatic arthritis and ankylosing spondylitis
25 January 2021 - Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where ...
Posted by Michael Wonder on 25 Jan 2021
EMA publishes agenda for 25-29 January CHMP meeting
25 January 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jan 2021
Coronavirus: Pfizer jab cleared for first rollout, with more planned
25 January 2021 - Pharmaceutical giant Pfizer says it is open to providing more doses of its vaccine to Australia ...
Posted by Michael Wonder on 25 Jan 2021
Calquence approved in Japan for the treatment of relapsed or refractory chronic lymphocytic leukaemia
25 January 2021 - 88% of patients on Calquence remained free of disease progression after 12 months vs. 68% for ...
Posted by Michael Wonder on 25 Jan 2021
TGA provisionally approves Pfizer/BioNTech COVID-19 vaccine for use in Australia
25 January 2021 - The Therapeutic Goods Administration has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia. ...