Blog
RSS FeedPosted by Michael Wonder on 04 May 2020
FDA approves Fensolvi (leuprolide acetate) for injectable suspension for paediatric patients with central precocious puberty
4 May 2020 - Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two ...
Posted by Michael Wonder on 29 Apr 2020
FDA approves Ortho Dermatologics' labeling for Jublia (efinaconazole) 10% topical solution in patients as young as six years old
29 April 2020 - Ortho Dermatologics today announced today announced the U.S. FDA has approved a supplemental new drug application for ...
Posted by Michael Wonder on 26 Apr 2020
Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
24 April 2020 - Submissions demonstrate Janssen’s commitment to developing new options for young patients. ...
Posted by Michael Wonder on 10 Apr 2020
FDA approves first therapy for children with debilitating and disfiguring rare disease
10 April 2020 - Today, the U.S. FDA approved Koselugo (selumetinib) for the treatment of paediatric patients, 2 years of age ...
Posted by Michael Wonder on 07 Apr 2020
Blaze Bioscience announces FDA has granted fast track designation to BLZ-100 (tozuleristide) for paediatric central nervous system tumours
7 April 2020 - Phase 2/3 pivotal trial ongoing in patients up to 30 years of age undergoing surgery for paediatric ...
Posted 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 ...