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RSS FeedPosted by Michael Wonder on 16 Jun 2020
FDA approves gemtuzumab ozogamicin for CD33-positive AML in paediatric patients
16 June 2020 - Today the FDA extended the indication of gemtuzumab ozogamicin (Mylotarg, Wyeth Pharmaceuticals) for newly-diagnosed CD33-positive acute ...
Posted by Michael Wonder on 15 Jun 2020
FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD
15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function ...
Posted by Michael Wonder on 12 Jun 2020
FDA approves drug to treat infants and children with HIV
12 June 2020 - Today, the U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for ...
Posted by Michael Wonder on 03 Jun 2020
Clarity Pharmaceuticals announces that the US FDA grants rare paediatric disease designation to Copper Cu 67 sartate for the treatment of neuroblastoma
3 June 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 01 Jun 2020
U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis
27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...
Posted by Michael Wonder on 27 May 2020
FDA approves first treatment for a form of bladder dysfunction in paediatric patients as young as 2 years of age
26 May 2020 - The U.S. FDA today granted approval to VESIcare LS (solifenacin succinate) oral suspension for the treatment of ...
Posted 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 ...