Japanese pharmaceutical firm Eisai has secured approval from the European Commission (EC) on the license extension application for the use of antiepileptic agent Zonegran (zonisamide) in the treatment of pediatric patients. The EC ...
Tags: Eisai Obtains, Zonegran
The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases
The US FDA has approved Silvergate Pharmaceuticals' Epaned (enalapril maleate Powder for Oral Solution) to treat hypertension (high blood pressure) in people aged one month and more. Silvergate Pharmaceuticals president and CEO Frank ...
The FDA has approved the use of Astellas Pharma US' Mycamine (micafungin sodium) for injection to treat pediatric patients aged four months and more with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, ...
The USFDA has granted priority review designation for investigational agent Metreleptin, jointly developed by Bristol-Myers Squibb Company and AstraZeneca, for the treatment of metabolic disorders associated with rare forms of ...
Masimo (MASI) has received the US FDA 510(k) clearance for its rainbow Acoustic Monitoring sensor, RAS-125c Acoustic Respiration Cloth Sensor for monitoring acoustic respiration rate (RRa) in pediatric patients. The RAS-125c Acoustic ...
Tags: Medicine, Monitoring Sensor
The US Food and Drug Administration (FDA) has granted orphan drug exclusivity to Hyperion's Ravicti (glycerol phenylbutyrate) liquid. Hyperion Therapeutics president and CEO Donald Santel said that the orphan drug exclusivity further ...
Tags: Hyperion, Ravicti Liquid
US-based medical devices manufacturer Varian Medical and Paul Scherrer Institute (PSI) have collaborated to further advance the motion management techniques for proton therapy. Focused on optimizing treatment strategies for cancer in the ...
Tags: Varian Medical, Proton Therapy
Mission Pharmacal Company has introduced new flavored Prednisolone Sodium Phosphate Oral Solution 25mg/5mL for asthma patients in certain US markets. The company expects to make the flavored asthma medicine, with grape taste and higher ...
Becton, Dickinson and Company (BD) has announced the FDA approval of first drug, diphenhydramine hydrochloride injection, USP, to be offered in BD Simplist line of prefilled generic injectables. Diphenhydramine Hydrochloride Injection, ...
Tags: FDA, drug, prefilled generic injectables
The US FDA has cleared Eisai's ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age. The approval was based on positive data from multicenter, ...
Tags: FDA, Disease Therapy for Children, Medicine
Galderma Laboratories has gained US marketing rights for its Epiduo (adapalene 0.1%/BPO 2.5%) Gel, designed for the treatment of acne in children as young as nine years old, following the approval from the US Food and Drug Administration ...
US-based Smiths Medical has gained US marketing rights for its CADD-Solis variable infusion profile (VIP) ambulatory infusion system, following the US Food and Drug Administration (FDA) approval. The multi-therapy infusion system, which ...
Tags: FDA, therapy infusion system, Medical
The US Food and Drug Administration (FDA) has approved L300 neurostimulation system, designed for treating children suffering from foot drop. The neuromuscular stimulation device, which also helps in treating children suffering from ...
Tags: FDA, L300 neurostimulation system, children, foot drop
Arizona Burn Center at Maricopa Medical Center, US has started deploying Diversionary Therapy Technologies' (DTT) ditto device for pediatric patients in its Burn Unit. The ditto device was gifted by Avnet, a distributor of electronic ...
Tags: Arizona Burn Center, Maricopa Medical Center, US, DTT ditto device