Blog
RSS FeedPosted by Michael Wonder on 30 Mar 2020
Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of paediatric patients with moderate to severe plaque psoriasis
30 March 2020 - Taltz is the first and only IL-17A antagonist approved to treat this population. ...
Posted by Michael Wonder on 24 Mar 2020
U.S. FDA approves supplemental new drug application for expanded indication of Eucrisa (crisaborole) 2% ointment in children as young as 3 months of age with mild-to-moderate atopic dermatitis
24 March 2020 - Eucrisa is the first and only 100% steroid-free, topical prescription medication approved for patients as young as ...
Posted by Michael Wonder on 19 Mar 2020
FDA approves new treatment for paediatric patients with any strain of hepatitis C
19 March 2020 - The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to ...
Posted by Michael Wonder on 02 Feb 2020
Bayer application for nifurtimox to treat paediatric patients with Chagas disease submitted for approval in US
30 January 2020 - Submission based on results of CHICO (CHagas disease In Children treated with NifurtimOx) phase III clinical study ...
Posted by Michael Wonder on 01 Feb 2020
FDA approves first drug for treatment of peanut allergy for children
31 January 2020 - Today the U.S. Food and Drug Administration approved Palforzia [peanut (arachis hypogaea) allergen powder-dnfp] to mitigate allergic ...
Posted by Michael Wonder on 30 Jan 2020
ProQR receives rare paediatric disease designation from FDA for QR-421a
30 January 2020 - Designation is for the treatment of patients with retinitis pigmentosa caused by mutations in exon 13 ...
Posted by Michael Wonder on 27 Jan 2020
FDA approves Merck’s Dificid (fidaxomicin) to treat Clostridioides difficile in children aged six months and older
27 January 2020 - Merck today announced the U.S. FDA has approved a new drug application for Dificid (fidaxomicin) for oral ...
Posted by Michael Wonder on 17 Jan 2020
Fortress Biotech announces rare paediatric disease designation for CUTX-101 for the treatment of Menkes disease
16 January 2020 - Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling new drug application for CUTX-101 ...
Posted by Michael Wonder on 09 Jan 2020
U.S. FDA approves supplemental new drug application for expanded indication of Mycamine (micafungin for injection) for the treatment of invasive candidiasis in paediatric patients less than 4 months of age
8 January 2020 - Astellas Pharma today announced that the U.S. FDA has approved its supplemental new drug application for ...
Posted by Michael Wonder on 09 Jan 2020
Aruvant receives FDA rare paediatric disease designation for ARU-1801 for the treatment of sickle cell disease
8 January 2020 - ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and ...
Posted by Michael Wonder on 06 Jan 2020
FDA approves Fiasp for treatment of children with diabetes
6 January 2020 - Novo Nordisk today announced that the U.S. FDA has approved Fiasp (insulin aspart injection) 100 u/mL for ...
Posted by Michael Wonder on 18 Dec 2019
Chondrial Therapeutics announces dosing of first patients in Phase 1 clinical program of CTI-1601 for treatment of Friedreich’s ataxia; CTI-1601 granted rare pediatric disease designation and fast track designation by U.S. FDA
18 December 2019 - Chondrial Therapeutics, a clinical-stage biotechnology company focused on developing treatments for rare diseases, with an initial ...
Posted by Michael Wonder on 13 Dec 2019
Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation
12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...
Posted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...
Posted by Michael Wonder on 02 Dec 2019
Diurnal files adrenal insufficiency drug Alkindi in US
2 December 2019 - Could become only treatment for children with the condition. ...