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RSS FeedPosted by Michael Wonder on 16 Jul 2020
Knopp Biosciences receives rare paediatric disease designation for Kv7 activator KB-3061 for treatment of KCNQ2 epileptic encephalopathy
15 July 2020 - Knopp Biosciences announced today that it has received rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 13 Jul 2020
Ipsen announces updated indication for Dysport (abobotulinumtoxinA) for the treatment of spasticity in children
10 July 2020 - Dysport is now FDA approved to treat both upper and lower limb spasticity in paediatric patients two ...
Posted by Michael Wonder on 10 Jul 2020
FDA approves expanded Botox (onabotulinumtoxinA) label for the treatment of paediatric patients with spasticity
9 July 2020 - Updated label now includes paediatric patients with lower limb spasticity caused by cerebral palsy. ...
Posted by Michael Wonder on 07 Jul 2020
Senhwa Biosciences's silmitasertib receives rare paediatric disease designation from U.S. FDA for treatment of recurrent sonic hedgehog medulloblastoma
7 July 2020 - Senhwa Biosciences today announced that the U.S. FDA granted rare paediatric disease designation for its drug silmitasertib, ...
Posted by Michael Wonder on 22 Jun 2020
FDA accepts supplemental biologics license application for Botox (onabotulinumtoxinA) for the treatment of paediatric patients with neurogenic detrusor overactivity
22 June 2020 - Application seeks to extend use of Botox for patients 5 to 17 years old. ...
Posted by Michael Wonder on 20 Jun 2020
Plakous Therapeutics receives rare paediatric disease and orphan drug designations for Protego-PDTM for the prevention of necrotising enterocolitis
18 June 2020 - Plakous Therapeutics has been granted orphan drug and rare paediatric disease designations for its human placental extract, ...
Posted by Michael Wonder on 20 Jun 2020
Ovid Therapeutics receives FDA rare paediatric disease designation for OV101 for the treatment of Angelman syndrome
19 June 2020 - Ovid Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease ...
Posted by Michael Wonder on 19 Jun 2020
Dicerna receives rare paediatric disease designation from U.S. FDA for nedosiran for the treatment of primary hyperoxaluria
18 June 2020 - Dicerna Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation for nedosiran, ...
Posted by Michael Wonder on 18 Jun 2020
FDA approves first therapy for rare disease that causes low phosphate blood levels, bone softening
18 June 2020 - Today, the U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and ...
Posted 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 ...