Krystle Vermes

The FDA has approved the Raindrop Near Vision Inlay, which can be used to improve near vision in patients with presbyopia.

The FDA is asking for more scientific data to support the safety and effectiveness of certain active ingredients in OTC topical antiseptic rubs, including hand sanitizers.

The FDA has granted Bristol-Myers Squibb's nivolumab (Opdivo) breakthrough therapy designation for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.

Avodart can be used as monotherapy for symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

Mylan has launched a generic version of GlaxoSmithKline's dutasteride (Avodart) capsules.

Sabril may be used as monotherapy for infantile spasms or in combination with other treatments for refractory partial complex seizures.

The risk evaluation and mitigation strategy for vigabatrin (Sabril) has been adjusted to remove certain elements.

FDA rules benzhydrocodone and acetaminophen (Adapaz) application not ready for approval yet.

The FDA has rejected KemPharm Inc's benzhydrocodone and acetaminophen (Adapaz), a potential abuse-deterrent treatment for acute pain.

Calcifediol (Rayaldee) extended-release tablets apprvoed for secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease.

The FDA has approved OPKO Health Inc's calcifediol (Rayaldee) extended-release tablets for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease who are vitamin D deficient.

Inovio Pharmaceuticals and GeneOne Life Science Inc have received approval to begin a phase 1 human trial for a Zika vaccine.

GoNitro is for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

The FDA has approved Espero Pharmaceuticals Inc's nitroglycerin sublingual powder (GoNitro) for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

The FDA strengthened its existing warnings about the risk of acute kidney injury while taking canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA has approved AspireAssist, a device intended to treat obese patients.

FDA requires manufacturer to expand patient usability study and product stress testing.

The FDA has rejected Adamis Pharmaceuticals Corporation's new drug application for a pre-filled epinephrine injection.

The FDA has approved Vaxchora, a vaccine that can prevent cholera caused by serogroup 01 in adults aged 18 to 64 years who are traveling to cholera-affected areas.

Pharmavite LLC is recalling specific lots of Nature Made products out of concern for possible Salmonella or Staphylococcus aureus contamination.

The FDA has issued a warning about the risks of taking high doses of OTC and prescription loperamide.

Step 1 for anyone who has Step 2 gold capsule dietary supplements in stock is to arrange for a return or to throw them away.

Generic products launched for myelodysplastic syndrome and episodic atrial fibrillation.

Mylan is launching generic equivalents to Celgene's Vidaza injection, 100 mg/vial, and GlaxoSmithKline's Rythmol SR.

The FDA has approved Allergan's nebivolol and valsartan (Byvalson) for the treatment of hypertension.

Cleocin solution treats serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci.

Mylan has launched clindamycin palmitate hydrochloride for oral solution USP, 75 mg/5mL, which is the generic version of Pharmacia and Upjohn's Cleocin solution.

Daclizumab (Zinbryta) treats adults with relapsing forms of multiple sclerosis.

Zinbryta is a long-acting injection that is self-administered by the patient every month.

The FDA has approved daclizumab (Zinbryta) as a treatment for adults with relapsing forms of multiple sclerosis.