Krystle Vermes

Vistogard treats patients who develop life-threatening toxicities within days of receiving cancer drugs.

Patients who receive an overdose of chemotherapy drugs will now have access to an emergency treatment called uridine triacetate.

The FDA has accepted for review Ocular Therapeutix's new drug application for sustained release dexamethasone to relieve ocular pain in patients post-ophthalmic surgery.

XSTAT 30 is typically used to control life-threatening bleeding in military settings.

The FDA is now allowing civilians to access XSTAT 30 wound dressing, an expandable, multi-sponge product typically used to control life-threatening bleeding in military settings.

Needle mechanism that delivers insulin fails to deploy or is delayed.

Through a voluntary field safety notification, Insulet Corporation is notifying consumers and health care professionals about a slight increase in reports in which the OmniPod's needle mechanism to deliver insulin fails to deploy or is delayed.

Heritage Pharmaceuticals Inc has launched verapamil 40 mg immediate-release tablets for the treatment of angina, arrhythmias, and essential hypertension.

The FDA is taking into consideration a once-daily formulation of AbbVie's ombitasvir, paritaprevir, and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak).

Bestmed LLC, a medical device distributor, is recalling its digital temple thermometer due to inaccurate readings.

The FDA has accepted Eisai Co Ltd's new drug application for a once-daily formulation of its anti-obesity treatment lorcaserin hydrochloride.

Stelara has already been approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in several countries.

Janssen is seeking FDA approval for ustekinumab as a Crohn's disease treatment.

The FDA has approved Novartis' Fluad, the first seasonal influenza vaccine containing an adjuvant.

Mylan has announced the US launch of clozapine orally disintegrating tablets, 25 mg and 100 mg, the generic version of Jazz Pharmaceutical's FazaClo.

Once-daily tablets treat type 2 diabetes in adults as an adjunctive treatment to diet and exercise to improve glycemic control.

Janssen Research and Development LLC has submitted a new drug application to the FDA for canagliflozin and metformin hydrochloride extended release (Invokamet XR).

Mylan has launched a generic version of Teva Pharmaceuticals' Adderall in 5 mg, 7.5 mg, 10 mg, 12.5 mg, 20 mg, and 30 mg doses.

As a result of implementation difficulties, the FDA announced that it will extend the pharmacy certification deadline for the clozapine risk evaluation and mitigation strategy program.

The FDA has accepted Sandoz's biologics license application for its proposed pegfilgrastim biosimilar.

Mylan is launching generic versions of Glucotrol, Axert, and Viramune extended-release tablets.

Etelcalcetide would be the first approval of a calcimimetic agent administered intravenously.

Inaffit LLC is voluntarily recalling Natureal, a product marketed as a weight-loss dietary supplement, due to undeclared sibutramine.

The FDA has accepted for review Amgen's new drug application for etelcalcetide to treat secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

The FDA has concluded that long-term use of clopidogrel does not increase or decrease the risk of death for patients with heart disease.

The FDA has accepted Espero Pharmaceuticals' new drug application for GoNitro, a product designed to treat an attack or prophylaxis of angina pectoris due to coronary artery disease.

Pharmacists urged to keep idarucizumab away from idarubicin in storage containers.

The Institute for Safe Medication Practices (ISMP) is alerting pharmacists about the risks of mixing up idarucizumab (Praxbind) with idarubicin.

The FDA has given breakthrough therapy designation to Daiichi Sankyo and Plexxikon Inc's investigational oral CSF-1R inhibitor pexidartinib to treat tenosynovial giant cell tumor.

The FDA has granted priority review for Acadia Pharmaceutical Inc's new drug application (NDA) for pimavanserin (Nuplazid) to treat psychosis associated with Parkinson's disease.