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RSS FeedPosted 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
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 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 14 May 2021
BridgeBio Pharma receives FDA fast track designation for investigational gene therapy for congenital adrenal hyperplasia
14 May 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation to BBP-631, an investigational adeno-associated ...
Posted by Michael Wonder on 10 May 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic
10 May 2021 - Today, the U.S. FDA expanded the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine for the prevention ...
Posted by Michael Wonder on 09 May 2021
‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
6 May 2021 - A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious ...
Posted by Michael Wonder on 05 May 2021
Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11
4 May 2021 - Pfizer expects to apply to the FDA in September for emergency authorisation to administer its coronavirus ...
Posted by Michael Wonder on 27 Apr 2021
Enzyvant resubmits biologics licence application to FDA for RVT-802 for paediatric congenital athymia
27 April 2021 - Enzyvant today announced the resubmission of the biologics licence application to the U.S. FDA for RVT-802, ...
Posted by Michael Wonder on 19 Apr 2021
ALK gains paediatric approval for its ragweed SLIT tablet in the USA
19 April 2021 - The approval is based on data from one of the largest-ever paediatric SLIT-tablet trials, involving over 1,000 ...
Posted by Michael Wonder on 14 Apr 2021
Moleculin awarded new rare paediatric disease designation from U.S. FDA for WP1066 for the treatment of ependymoma
14 April 2021 - Moleculin Biotech announced today that the U.S. FDA has granted rare paediatric disease designation to its ...
Posted by Michael Wonder on 05 Apr 2021
FDA approvals strengthen Octapharma USA paediatric critical care product portfolio
30 March 2021 - Octaplas and fibryga receive new product labeling following FDA’s approval of BLA supplements to update therapy ...
Posted by Michael Wonder on 29 Mar 2021
Mezzion announces resubmission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
28 March 2021 - Submitted for FDA priority review as a rare paediatric disease product application. ...
Posted by Michael Wonder on 25 Mar 2021
FDA approves new indication for drug to treat neurogenic detrusor overactivity in paediatric patients
25 March 2021 - Today, the U.S. FDA approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron ...
Posted by Michael Wonder on 23 Mar 2021
Pacira announces FDA approval of supplemental new drug application for Exparel (bupivacaine liposome injectable suspension) in paediatric patients
22 March 2021 - Exparel is the first and only FDA approved long-acting local analgesic for children aged six and over. ...