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RSS FeedPosted by Michael Wonder on 20 Jul 2022
FDA approves Qsymia for the treatment of obesity in adolescents ages 12-17
20 July 2022 - Vivus today announced that the U.S. FDA approved Qsymia (phentermine and topiramate extended-release capsules) for use in ...
Posted by Michael Wonder on 19 Jul 2022
Wugen receives US FDA fast track and rare paediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL
19 July 2022 - Wugen, today announced that the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 09 Jul 2022
Pfizer and BioNTech announce U.S. FDA approval of their COVID-19 vaccine Comirnaty for adolescents 12 through 15 years of age
8 July 2022 - Approval of the two dose primary series is based on the totality of data through six months ...
Posted by Michael Wonder on 07 Jul 2022
US FDA awards rare paediatric disease designation to paxalisib for AT/RT, a rare form of childhood brain cancer
6 July 2022 - Kazia Therapeutics is pleased to announce that the U.S. FDA has awarded rare paediatric disease designation ...
Posted by Michael Wonder on 27 Jun 2022
FDA approves treatment for chronic weight management in certain paediatric patients aged 12 years and older
27 June 2022 - The U.S. FD has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic ...
Posted by Michael Wonder on 22 Jun 2022
U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children
22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...
Posted by Michael Wonder on 18 Jun 2022
Moderna receives FDA authorisation for emergency use of its COVID-19 vaccine for children 6 months of age and older
17 June 2022 - mRNA-1273 has been administered to millions of children and adolescents over the age of 6 worldwide, ...
Posted by Michael Wonder on 18 Jun 2022
Pfizer-BioNTech COVID-19 vaccine receives FDA emergency use authorisation for children 6 months through 4 years of age
17 June 2022 - In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this ...
Posted by Michael Wonder on 07 Jun 2022
FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate to severe atopic dermatitis
7 June 2022 - Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy ...
Posted by Michael Wonder on 07 Jun 2022
FDA approves drug for prevention of organ rejection in paediatric recipients of heart and liver transplants
7 June 2022 - The FDA has expanded the use of CellCept (mycophenolate mofetil) to prophylaxis of organ rejection in ...
Posted by Michael Wonder on 06 Jun 2022
GBT’s inclacumab and GBT601 receive U.S. FDA orphan drug and rare paediatric disease designations for the treatment of sickle cell disease
6 June 2022 - Inclacumab is a novel P selectin inhibitor currently in Phase 3 clinical trials to reduce vaso-occlusive ...
Posted by Michael Wonder on 02 Jun 2022
Pfizer asks FDA to authorise COVID-19 vaccine for youngest kids
1 June 2022 - Pfizer and BioNTech announced Wednesday that they have completed their submission requesting emergency use authorisation from ...
Posted by Michael Wonder on 31 May 2022
FDA approves label extension for Evrysdi for infants with spinal muscular atrophy under 2 months old
31 May 2022 - Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to ...
Posted by Michael Wonder on 25 May 2022
Noveome Biotherapeutics receives rare paediatric disease designation and orphan drug designation for the treatment of necrotising enterocolitis in neonates
24 May 2022 - Noveome Biotherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation and orphan drug ...
Posted by Michael Wonder on 24 May 2022
Neuronascent receives FDA rare paediatric drug designation for NNI-351 treatment for Fragile X syndrome
24 May 2022 - Neuronascent today announced that the US FDA granted rare paediatric designation for NNI-351 for Fragile X ...