Blog
RSS FeedPosted by Michael Wonder on 26 May 2020
FDA approves Dupixent (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
26 May 2020 - In the pivotal trial, more than twice as many children achieved clear or almost clear skin and ...
Posted by Michael Wonder on 22 May 2020
Passage Bio receives rare paediatric disease designation for PBGM01 for patients with GM1 gangliosidosis
21 May 2020 - PBGM01 to enter the clinic in fourth quarter of 2020. ...
Posted by Michael Wonder on 18 May 2020
Seelos Therapeutics receives rare paediatric disease designation for SLS-005 (trehalose) in Sanfilippo syndrome
15 May 2020 - Seelos Therapeutics today announced it has been granted rare paediatric disease designation for SLS-005 in Sanfilippo ...
Posted by Michael Wonder on 07 May 2020
FDA grants paediatric disease designation for Mateon's CA4P
5 May 2020 - Treatment of stage IIB–IV melanoma due to genetic mutations that disproportionately affect paediatric patients. ...
Posted 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 ...