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RSS FeedPosted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...
Posted by Michael Wonder on 24 Jul 2021
Dalvance (dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in paediatric patients
23 July 2021 - Dalvance is the first and only single dose infusion to treat acute bacterial skin and skin structure ...
Posted by Michael Wonder on 22 Jul 2021
FDA approves treatment for paediatric patients with type 2 diabetes mellitus
22 July 2021 - The U.S. FDA today approved Bydureon and Bydureon BCise (exenatide extended release) injection to be used in ...
Posted by Michael Wonder on 01 Jul 2021
LEXEO Therapeutics receives rare paediatric disease designation and orphan drug designation for LX2006 for the treatment of Friedreich’s ataxia
30 June 2021 - Phase I/II clinical trial in patients with cardiomyopathy associated with Friedreich’s ataxia expected to initiate in 2021. ...
Posted by Michael Wonder on 25 Jun 2021
Rivaroxaban application submitted to U.S. FDA for approval to treat VTE and to prevent VTE in children
23 June 2021 - Application seeks two paediatric indications, including an age-appropriate new weight-based oral suspension formulation. ...
Posted by Michael Wonder on 21 Jun 2021
FDA approves first oral blood thinning medication for children
21 June 2021 - Today, the U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less ...
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
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 ...