Krystle Vermes

FDA finds Kyndrisa was not ready for approval due to insufficient evidence of efficacy.

BioMarin Pharmaceutical Inc's new drug application for drisapersen as a treatment for Duchenne muscular dystrophy has been rejected by the FDA.

Perrigo Company is recalling its children's guaifenesin grape liquid and guaifenesin dextromethorphan cherry liquid because of a potential defect with the dosage cup.

Tenofovir alafenamide is a once-daily treatment for adults with chronic hepatitis B virus infection.

Tenofovir alafenamide is a once-daily treatment for adults with chronic hepatitis B virus infection.

Gilead Sciences Inc has submitted a new drug application to the FDA for tenofovir alafenamide, a once-daily treatment for adults with chronic hepatitis B virus infection.

Mylan has submitted an abbreviated new drug application to the FDA for a generic equivalent to GlaxoSmithKline's Advair Diskus.

Caregivers will be able to monitor glucose data and administer insulin right from the pump.

Caregivers will be able to monitor glucose data and administer insulin right from the pump.

Children ages 2 to 17 years will now be allowed to use the Animas Vibe insulin pump and continuous glucose monitoring system for diabetes management.

The FDA has accepted for review Sanofi and Regeneron Pharmaceuticals' biologics license application for sarilumab.

Hospira Inc is voluntarily recalling 1 lot of magnesium sulfate in water for injection.

Health care professionals advised product may have decreased potency due to oxidation.

A generic equivalent of Janssen's norgestimate/ethinyl estradiol tablets has been launched in the United States by Teva Pharmaceutical Industries.

The FDA has given priority review status to a new drug application for Gilead Sciences' sofosbuvir and velpatasvir as a treatment for chronic genotype 1-6 hepatitis C virus infection.

Sterile drug compounder Pharmedium is voluntarily recalling multiple lots of norepinephrine bitartrate added to 0.9% sodium chloride in light of complaints from hospitals of a slight discoloration in the mixture.

New drug application filed for fixed-ratio combination of insulin glargine and lixisenatide.

Bee Extremely Amazed has issued a voluntary recall of 14 products marketed for weight loss.

The FDA has given final approval to Aurobindo Pharma Limited to manufacture and market olopatadine hydrochloride ophthalmic solution, a generic equivalent of Alcon Laboratories Inc's Patanol drops.

Nuway Distributors is voluntarily recalling all lots of APEXXX tablets, a dietary supplement marketed for male sexual enhancement.

Sanofi has submitted a new drug application to the FDA for a fixed-ratio combination of insulin glargine and lixisenatide.

The FDA has expanded the age indication of Merck's human papillomavirus 9-valent vaccine for men.

The FDA has approved the use of the LifeVest wearable defibrillator among children at risk for sudden cardiac arrest who are not eligible for an implantable defibrillator.

The FDA has approved selexipag tablets to treat pulmonary arterial hypertension among adults.

Basaglar improves glycemic control among adult and pediatric patients with type 1 diabetes and among adults with type 2 diabetes.

The FDA has approved insulin glargine injection, a long-acting human insulin analog to improve glycemic control among adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes.

Treatment reverses the effects of neuromuscular blockade created by rocuronium bromide and vercuronium bromide.

The FDA has approved sugammadex (Bridion) to reverse the effects of neuromuscular blockade created by rocuronium bromide and vercuronium bromide.

The FDA has approved bendamustine hydrochloride injection as a treatment for chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma.

Allergan's eluxadoline, a treatment for irritable bowel syndrome with diarrhea, is now available by prescription.