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RSS FeedPosted by Michael Wonder on 09 Feb 2023
Eylea (aflibercept) injection approved as the first pharmacological treatment for preterm infants with retinopathy of prematurity by the FDA
8 February 2023 - Eylea now approved to treat five retinal conditions caused by ocular angiogenesis. ...
Posted by Michael Wonder on 04 Feb 2023
US FDA approves Takeda’s Takhyzro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
3 February 2023 - Approval supported by extrapolation of efficacy data from the Phase 3 HELP study with additional data from ...
Posted by Michael Wonder on 01 Feb 2023
FLAG Therapeutics receives rare paediatric disease designation for FLAG-003 for the treatment of children with diffuse intrinsic pontine glioma
31 January 2023 - FLAG Therapeutics announced today that FLAG-003, an investigational small molecule therapy for the treatment of diffuse intrinsic ...
Posted by Michael Wonder on 01 Feb 2023
Mesoblast resubmits biologic license application to FDA for remestemcel-L in children with steroid-refractory acute graft versus host disease
31 January 2023 - New 4 year data from the Phase 3 trial shows durable long term survival outcomes. ...
Posted by Michael Wonder on 25 Jan 2023
US FDA approves ALK's Odactra (house dust mite allergen extract) tablet for sublingual use as immunotherapy for adolescents
25 January 2023 - Odactra is now indicated to treat house dust mite-induced allergic rhinitis, with or without conjunctivitis, in persons ...
Posted by Michael Wonder on 19 Jan 2023
Synlogic receives rare paediatric disease designation from FDA for SYNB1934 for phenylketonuria
19 January 2023 - Synlogic today announced that SYNB1934 was granted rare paediatric disease designation by the US FDA for the ...
Posted by Michael Wonder on 19 Jan 2023
FDA grants rare paediatric disease status to GC Pharma’s San Filippo syndrome therapy
18 January 2023 - GC Pharma said on Wednesday that its San Filippo Syndrome type A treatment, jointly being developed ...
Posted by Michael Wonder on 17 Jan 2023
Orphagen Pharmaceuticals receives rare paediatric disease designation from FDA for OR-449 for the treatment of paediatric adrenocortical carcinoma
17 January 2023 - Orphagen Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for OR-449 ...
Posted by Michael Wonder on 06 Jan 2023
AUM Biosciences receives US FDA rare paediatric disease designation for AUM302 for treatment of neuroblastoma
5 January 2023 - AUM Biosciences announced today that the US FDA has granted a rare paediatric disease designation for its ...
Posted by Michael Wonder on 05 Jan 2023
Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
5 January 2023 - Submission supported by comprehensive clinical trial programme, which demonstrated protection against RSV disease through the RSV ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 30 Dec 2022
FDA approves once weekly Wegovy injection for the treatment of obesity in teens aged 12 years and older
24 December 2022 - New indication based on clinical trial that demonstrated a 16.1% reduction in body mass index (BMI) in ...
Posted by Michael Wonder on 17 Dec 2022
AbbVie submits supplemental new drug application to US FDA to support new indication of Linzess (linaclotide) for functional constipation in children and adolescents 6 to 17 years of age
16 December 2022 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases ...
Posted by Michael Wonder on 08 Dec 2022
FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age
8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...
Posted by Michael Wonder on 06 Dec 2022
Pfizer and BioNTech submit application to US FDA for emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine in children under 5 years
5 December 2022 - Pfizer andBioNTech today announced that the companies have submitted an application to the US FDA for ...