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RSS FeedPosted by Michael Wonder on 02 Feb 2022
QSAM Biosciences receives rare paediatric disease designation from FDA for CycloSam in the treatment of osteosarcoma
2 February 2022 - QSAM Biosciences today announces that the United States FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 01 Feb 2022
Pfizer and BioNTech initiate rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age following request from U.S. FDA
1 February 2022 - Companies plan to submit additional data on a third 3 µg dose in this age group in ...
Posted by Michael Wonder on 27 Jan 2022
Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour
24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...
Posted by Michael Wonder on 26 Jan 2022
Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency
25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...
Posted by Michael Wonder on 25 Jan 2022
Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy
24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...
Posted by Michael Wonder on 21 Jan 2022
Pfizer and OPKO provide update on the biologics license application for somatrogon for paediatric growth hormone deficiency
21 January 2022 - Pfizer and OPKO Health announced today that the U.S. FDA issued a complete response letter for the ...
Posted by Michael Wonder on 07 Jan 2022
Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17
6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti ...
Posted by Michael Wonder on 05 Jan 2022
U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer
3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...
Posted by Michael Wonder on 03 Jan 2022
FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine
3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...
Posted by Michael Wonder on 26 Dec 2021
Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis related arthritis and psoriatic arthritis
22 December 2021 - New approvals are based on JUNIPERA trial data showing Cosentyx (secukinumab) demonstrated reduced flare risk versus placebo ...
Posted 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 ...