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RSS FeedPosted by Michael Wonder on 22 Dec 2021
FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations
20 December 2021 - FDA has approved Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism, or blood ...
Posted by Michael Wonder on 19 Dec 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for the treatment of paediatric patients with iron deficiency anaemia
15 December 2021 - For patients as young as one year of age who have intolerance to, or have had ...
Posted by Michael Wonder on 18 Dec 2021
Pfizer and BioNTech submit supplemental biologics license application for U.S. FDA approval of Comirnaty in adolescents 12 through 15 years of age
16 December 2021 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the U.S. ...
Posted by Michael Wonder on 18 Dec 2021
bluebird bio announces FDA priority review of biologics license application for eli-cel gene therapy for cerebral adrenoleukodystrophy in patients without a matched sibling donor
17 December 2021 - If approved, eli-cel will be the first and only gene therapy for the treatment of cerebral adrenoleukodystrophy, ...
Posted by Michael Wonder on 18 Dec 2021
FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
17 December 2021 - The FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in paediatric ...
Posted by Michael Wonder on 09 Dec 2021
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16 and 17 year olds
9 December 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine, authorising the use ...
Posted by Michael Wonder on 07 Dec 2021
FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options
7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...
Posted by Michael Wonder on 04 Dec 2021
FDA expands authorisation of two monoclonal antibodies for treatment and post-exposure prevention of COVID-19 to younger paediatric patients, including newborns
3 December 2021 - Today, the U.S. FDA revised the emergency use authorisation of bamlanivimab and etesevimab (previously authorised for paediatric ...
Posted by Michael Wonder on 03 Dec 2021
FDA approves rituximab plus chemotherapy for paediatric cancer indications
3 December 2021 - On 2 December 2021, the FDA approved rituximab (Rituxan, Genentech) in combination with chemotherapy for pediatric ...
Posted by Michael Wonder on 01 Dec 2021
U.S. FDA accepts for priority review the supplemental biologics license application for Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for use in infants and children
1 December 2021 - Merck today announced the U.S. FDA has accepted for priority review a supplemental biologics license application for ...
Posted by Michael Wonder on 29 Nov 2021
U.S. Food and Drug Administration approves Longeveron’s Lomecel-B for rare paediatric disease designation to treat life-threatening infant heart condition
18 November 2021 - Phase 2 clinical trial underway for hypoplastic left heart syndrome, which affects approximately 1,000 babies per ...
Posted by Michael Wonder on 20 Nov 2021
FDA approves first drug to improve growth in children with most common form of dwarfism
19 November 2021 - Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five ...
Posted by Michael Wonder on 04 Nov 2021
OS Therapies receives rare paediatric disease designation in osteosarcoma for OST-HER2 (Listeria monocytogenes)
3 November 2021 - Pathway to priority review voucher and expedited review by the FDA. ...
Posted by Michael Wonder on 31 Oct 2021
FDA authorises Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
29 October 2021 - Today, the U.S. FDA authorised the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of ...
Posted by Michael Wonder on 20 Oct 2021
FDA expands approval of Dupixent (dupilumab) to include children aged 6 to 11 years with moderate to severe asthma
20 October 2021 - Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years ...