Krystle Vermes

Entecavir treats chronic hepatitis B infection in adults with evidence of active viral replication.

The FDA has expanded the use of Sunovion's anticonvulsant eslicarbazepine acetate (Aptiom) as monotherapy for partial-onset seizures.

A generic equivalent to Bristol-Myers Squibb's entecavir (Baraclude) hepatitis B treatment has been approved by the FDA.

Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes may cause severe and disabling joint pain, the FDA has warned.

Amgen is seeking FDA approval for etelcalcetide, the first calcimimetic agent administered intravenously after dialysis to treat secondary hyperparathyroidism in patients with chronic kidney disease.

Pharmacies are now stocking Mylan's generic version of Pfizer's Zosyn injection.

FDA previously expanded Botox label for the treatment of upper limb spasticity.

Ingenol mebutate (Picato) gel's label must now include reported risks of shingles and anaphylaxis.

The FDA has accepted Allergan's resubmission to approve the use of onabotulinumtoxinA (Botox) for lower limb spasticity in adults.

The FDA has fast-tracked Cempra's solithromycin to treat community acquired bacterial pneumonia.

Keytruda is currently approved for patients with unresectable or metastatic melanoma.

A new 200-units/mL formulation of Lilly's pre-filled insulin pen containing rapid-acting insulin lispro is now available at pharmacies for patients with diabetes.

The FDA is considering expanding the use of Merck's pembrolizumab as a first-line treatment for advanced melanoma.

Nephropathic cystinosis drug Procysbi now available in delayed-release capsules for young children.

Pharmacists should not use compounded drugs stored in 3-mL and 5-mL syringes from Becton-Dickinson unless no suitable alternatives are available, the FDA warns.

Treatment provides antibacterial option for preoperative prophylaxis treatment.

The FDA has expanded the use of Raptor Pharmaceutical's cysteamine bitartrate delayed-release capsules to treat nephropathic cystinosis in children ages 2 to 6.

Sprycel label now includes 5-year first-line efficacy and safety data in adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.

The FDA has approved Baxter and Water Street's cefazolin 2 g injection in a frozen premix, providing another cephalosporin antibacterial option for preoperative prophylaxis treatment.

The FDA has approved a product labeling update for Bristol-Myers Squibb and Otsuka's chronic myeloid leukemia (CML) drug dasatinib (Sprycel)

The FDA could soon approve Teva's deutetrabenazine for the treatment of chorea associated with Huntington disease, a rare and fatal neurodegenerative disorder.

The FDA is considering a label change for Lundbeck and Takeda's vortioxetine to describe the drug's effect on certain aspects of cognitive dysfunction in adults with major depressive disorder.

Mylan has launched its lidocaine patch 5%, the generic version of Endo Pharmaceutical's Lidoderm.

Cook Medical is recalling nearly 40,000 angiographic catheters following 26 reports of malfunction, nearly half of which resulted in adverse events.

Test targets non-small cell lung cancer patients with an acquired resistant mutation.

Roche is seeking FDA premarket approval of its companion diagnostic test for AstraZeneca's investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.

The FDA is alerting health care professionals about serious adverse effects reported with implantable left ventricular assist devices (LVADs).

Bausch and Lomb's Victus femtosecond laser platform has received clearance from the FDA for an enhanced patient interface kit.

Baxter is recalling 1 lot of its 0.9% sodium chloride injection due to customer complaints of leaking containers, particulate matter, and missing port protectors, which could result in contamination.