Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
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Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.
The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
The proposed legislation, sponsored by Sens. Chuck Grassley and Maria Cantwell, aims to increase transparency of PBM business practices.
Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.
CalRx will work with Civica to provide the most commonly used short- and long-acting insulins at planned prices of no more than $30 a vial and $55 for a box of five pre-filled pens.
Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.
In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
Evkeeza treats a rare form of high cholesterol. It is now approved for patients as young of 5 years of age.
The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance.
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Illuccix is for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
The patient groups say the insurer is cutting off access to important medications. The Tennessee Blues plans say many of the drugs that it excluded from coverage have zero utilization.
Medicare Part B beneficiaries are expected to save between $2 and $390 per average dose starting April 1, 2023.
Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.
The lower prices will take effect on Jan. 1, 2024, on both pre-filled pens and vials of basal, bolus and pre-mix insulins, including Levemir, Novolin, NovoLog and NovoLog Mix 70/30.
The VA’s guidelines would exclude anyone who has had a stroke or seizure within the last year, as well as those who have MRIs that show evidence of microhemmorrhages, aneurysms, lesions or tumors.
Daybue will be available by the end of April with a list price of about $375,000 annually.
Aponvie is the first intravenous version of aprepitant adults to prevent postoperative nausea and vomiting.
Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.
Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved for patients with acute migraine.
Radicava ORS will be available with a national prior authorization process in place.
Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.
Payers are looking to pharmaceutical companies for innovative partnerships that provide patient access, positive clinical outcomes and reduced costs in specialty disease areas, AmerisourceBergen finds.
If approved, Jardiance would be the first SGLT2 inhibitor indicated for this population. A decision is expected in the second quarter of 2023.
Voxzogo is already available to treat patients older than five years with a genetic cause of dwarfism. The FDA has set a PDUFA of Oct. 21, 2023, for children younger than 5.
If approved, berdazimer could be the first prescription product treat molluscum, a common skin infection caused by poxvirus. The Prescription Drug User Fee Act goal date is Jan. 5, 2024.
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