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RSS FeedPosted by Michael Wonder on 15 Jun 2021
Moderna seeks vaccine approval for adolescents
11 June 2021 - US-based biotech company Moderna is applying for the use of its COVID-19 vaccine for adolescents aged 12 ...
Posted by Michael Wonder on 11 Jun 2021
Sanofi provides update on Aubagio (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S
11 June 2021 - The U.S. FDA has issued a complete response letter regarding the supplemental new drug application for ...
Posted by Michael Wonder on 11 Jun 2021
Moderna files for emergency use authorisation for its COVID-19 vaccine in adolescents in the United States
10 June 2021 - Submission based on Phase 2/3 trial of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 11 Jun 2021
U.S. FDA approves new formulation of Epclusa, expanding paediatric indication to treat children ages 3 and older with chronic hepatitis C
10 June 2021 - Gilead Sciences announced today that the U.S. FDA has approved an expansion of the pediatric indication of ...
Posted by Michael Wonder on 09 Jun 2021
Australia tipped to approve Pfizer vaccine for children this year
9 June 2021 - Infectious diseases paediatricians and vaccine experts anticipate the Pfizer shot could be approved for use in ...
Posted by Michael Wonder on 09 Jun 2021
Vertex announces U.S. FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
9 June 2021 - With this approval approximately 1,500 children with one minimal function mutation and one F508del mutation have a ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 07 Jun 2021
MHRA authorises Pfizer/BioNTech’s COVID-19 vaccine for 12 to 15 year-olds
7 June 2021 - The UK MHRA has extended the authorisation of Pfizer/BioNTech’s COVID-19 vaccine for use in children aged ...
Posted by Michael Wonder on 07 Jun 2021
TGA investigating Pfizer jabs for children over 12
7 June 2021 - Australia’s medical regulator is considering allowing children over the age of 12 to be vaccinated with ...
Posted by Michael Wonder on 03 Jun 2021
'We're not just all about the money' — PHARMAC defends why it still won't fund drug for rare children's disorder
3 June 2021 - Under-fire PHARMAC is defending the way it funds New Zealand's drugs, with the agency's director of operations, ...
Posted by Michael Wonder on 01 Jun 2021
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
1 June 2021 - The safety profile of Cosentyx in paediatric patients with plaque psoriasis was demonstrated in two Phase ...
Posted by Michael Wonder on 28 May 2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU
28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 26 May 2021
Colchester baby's parents feel 'abandoned' over £1.7 million drug
25 May 2021 - A baby with a fatal genetic condition has been "abandoned" in a "race against time" for ...
Posted by Michael Wonder on 25 May 2021
Jacinda Ardern listening to calls for PHARMAC to fund 13 year old's life-changing drugs, but nothing she can do
25 May 2021 - Prime Minister Jacinda Ardern says she's listening to calls for life-changing drugs to be made more ...