Tag: Food & Drug Administration
FDA Approves Emflaza for Duchenne Muscular Dystrophy
Approved to treat Duchenne muscular dystrophy in patients 5 years and older
FDA Approves Newborn Screening Tests for Metabolic Disorders
Screens used to detect Mucopolysaccharidosis Type 1, Pompe, Gaucher, and Fabry
Extending Rx Exclusivity Could Boost Study for Rare Diseases
Substantial compensation to many drug manufacturers, especially for top-selling products
FDA Approves Trulance for Chronic Idiopathic Constipation
Drug designed to stimulate secretion of intestinal fluid
FDA, EPA Issue Guidance on Fish Consumption
Recommendations aimed at pregnant women, breastfeeding mothers, parents of young children
Excessive FDA Regulation Driving High Drug Prices
First-in-class drugs are fast-tracked while follow-on drugs can take up to 15 years to be approved
FDA Grants Fast-Track Approval to Ovarian Cancer Drug
Rubraca's use is specific to women with deleterious BRCA mutations
FDA OKs Autologous Cellularized Scaffold for Knee Cartilage Repair
For symptomatic, full-thickness cartilage defects of the knee in adult patients
FDA Approves Intrarosa for Postmenopausal Pain During Sex
Drug contained in a once-daily vaginal insert
FDA Approves Device to Prevent Recurrent Strokes in PFO Patients
For patients who had prior stroke related to patent foramen ovale
