News from the FDA/CDC
News from the FDA/CDC
FDA approves Dayvigo for insomnia
The orexin receptor antagonist will be available in 5-mg and 10-mg tablets after DEA scheduling.
News
FDA warns gabapentin, pregabalin may cause serious breathing problems
The drugs increase the risk of respiratory depression when used with central nervous system depressants or in patients with lung problems,...
News from the FDA/CDC
FDA approves Vyondys 53 for Duchenne muscular dystrophy subtype
The agency also authorized the first newborn screening test for DMD.
News from the FDA/CDC
First generics for Gilenya approved by FDA
Approvals for fingolimod generics were issued to three companies.
News from the FDA/CDC
FDA approves Givlaari for treatment of acute hepatic porphyria
Prior to this approval, existing treatments provided only partial relief from porphyria attacks, according to the FDA.
Feature
President to nominate oncologist to lead FDA
President Trump has indicated his intent to nominate Stephen Hahn, MD, as FDA Commissioner.
News from the FDA/CDC
FDA approves diroximel fumarate for relapsing MS
The oral drug, marketed as Vumerity, converts to the same active metabolite as dimethyl fumarate.
News from the FDA/CDC
FDA approves onabotulinumtoxinA for pediatric lower limb spasticity
The indication excludes spasticity related to cerebral palsy.
News from the FDA/CDC
FDA approves Reyvow for acute migraine treatment
The approval of lasmiditan (Reyvow) is based on a pair of randomized, double-blind, placebo-controlled trials that included more than 3,000...
FDA/CDC
FDA expands Dysport’s upper-limb spasticity indication to children
AbobotulinumtoxinA (Dysport) is now approved for upper-limb spasticity in both children 2 years and older (excluding those with cerebral palsy)...
News from the FDA/CDC
FDA approves istradefylline for Parkinson’s disease