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China NMPA Accepts IND Application for Eftansomatropin Pivotal Trial in Pediatric Patients with Growth Hormone Deficiency prnasia
August 04, 2020
I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the China National Medical Products Administration (NMPA) has accepted
FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C fda
March 20, 2020
The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six
FDA Approves New Treatment for Pediatric Patients with Type 2 Diabetes americanpharmaceuticalreview
June 20, 2019
The U.S. Food and Drug Administration (FDA) approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients
Significant Number of Referred Patients Misdiagnosed With MS drugs
April 28, 2019
Among pediatric patients with relapsing multiple sclerosis, fingolimod is associated with a lower rate of relapse but a higher rate of serious adverse events than interferon beta-1a, according to a study published in the Sept.
Bayer's Ph III clinical trial of Nifurtimox in pediatric patients with Chagas Disease meets primary endpoint biospectrumasia
March 18, 2019
Chagas is an infectious disease caused by a parasite (Trypanosoma cruzi) and transmitted to humans via the feces of triatomines, also known as kissing bugs.
Valbenazine Did Not Meet Primary Endpoint in Pediatric Patients with Tourette Syndrome americanpharmaceuticalreview
December 13, 2018
Neurocrine Biosciences announced topline data from the Phase IIb T-Force GOLD study demonstrating that valbenazine did not meet the primary endpoint .....
Fingolimod Cuts Multiple Sclerosis Relapses in Pediatric Patients drugs
September 13, 2018
Among pediatric patients with relapsing multiple sclerosis, fingolimod is associated with a lower rate of relapse but a higher rate of serious adverse events than interferon beta-1a, according to a study published in the Sept. 13 issue of the New England
Larotrectinib shows promise in paediatric patients with TRK gene mutations europeanpharmaceuticalreview
April 09, 2018
A new cancer drug has proven safe and effective for paediatric patients with a rare tumour gene mutation…
FDA Approves Two Hepatitis C Drugs for Pediatric Patients americanpharmaceuticalreview
April 11, 2017
The U.S. Food and Drug Administration has approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat
Shire Receives European Approval for Label Extension of CINRYZE to Prevent and Treat Hereditary Angi americanpharmaceuticalreview
March 17, 2017
Shire announced that the European Commission (EC) has approved a label extension granting three new indications for CINRYZE® (C1 inhibitor [human])...