Tag Archives: pediatric

U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 10, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV… Read More »

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

DUBLIN, March 30, 2021 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for this indication… Read More »

ESC: Amgen chases pediatric use for cholesterol-busting PCSK9 med Repatha

Amgen’s Repatha and Sanofi and Regeneron’s Praluent have been locked in a heated battle for supremacy in the pricey PCSK9 cholesterol-cutting market. Looking to angle its way to an advantage, Amgen is looking to adolescent patients with a rare disorder causing high cholesterol levels.  Adolescent patients with a genetic disorder tied to abnormally high cholesterol… Read More »

FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis

Print this page NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of Sirturo (bedaquiline). Sirturo is now indicated for use as part of combination therapy in the treatment of adult… Read More »

Why is pediatric asthma on the rise

Hyderabad: As much as It has been found that 1 in 10 Indian children is found to suffer from asthma. The prevalence the childhood asthma in the year was 4. This number is now found to have risen to 5. Childhood or pediatric asthma is the most common and serious chronic disease found in infants… Read More »