US Food and Drug Administration (FDA)

US Senate confirms Scott Gottlieb as new FDA commissioner

Scott Gottlieb has been confirmed as the new commissioner of the US Food and Drug Administration in a Senate vote (of 57 to 42). The decision, confirmed on 9 May 2017, has not been without controversy, however, as Gottlieb has links to the pharmaceutical industry, where he has earned hundreds …

Amyotrophic lateral sclerosis treatment approved by FDA

The US Food and Drug Administration has approved the drug edaravone (Radicava, MT Pharma America, Inc.) for the treatment of patients with amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.…

Link between azithromycin and arrhythmia because of confounding by indication, say researchers

New study of antibiotic users shows no extra risk of ventricular arrhythmia for current azithromycin users than for current users of amoxicillin.…

Midostaurin approved by FDA for newly diagnosed adults with AML

The US Food and Drug Administration (FDA) has approved midostaurin (Rydapt; Novartis) for use in combination with chemotherapy by newly diagnosed acute myeloid leukaemia (AML) patients who have the specific gene mutation, FLT3. Midostaurin is a kinase inhibitor that works by blocking several e…

FDA approves new treatment for young children with Batten disease

The first drug of its kind to be made available in the United States for children with a specific form of the inherited disorder, Batten disease, has been approved by the US Food and Drug Administration (FDA).…

FDA restricts use of codeine and tramadol in children

The US drug regulator has issued restrictions on codeine and tramadol in children’s medicines.…

FDA approves first drug for tardive dyskinesia

The US Food and Drug Administration, which is responsible for evaluating the safety and efficacy of medicines in the United States, has given the green light to valbenazine (Ingrezza), the first drug to be approved for treating adults with tardive dyskinesia.…

FDA approves first direct-acting antivirals for adolescents with hepatitis C

The US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C in adolescents aged 12–17 years.…

FDA approves Austedo for Huntington’s chorea

The US Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine) for the treatment of chorea associated with Huntington’s disease.…

FDA approves drugs three to four months faster than the EMA

The United States medicines safety watchdog approves more new drugs and is faster than its peer agency in Europe, according to the results of a study published in the New England Journal of Medicine.…