An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.
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Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.
Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.
The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.
More than half of those survey by KFF who were disenrolled from Medicaid said they put off needed medical care because of costs.
Jeffrey Casberg, M.S., R.Ph., a senior vice president of clinical pharmacy at IPD Analytics LLC, a drug intelligence firm that advises payers and pharmaceutical companies, talks about how payers are thinking about weight-loss drugs.
Fasenra is now approved to treat patients aged 6 and older with eosinophilic asthma, a rare form of asthma.
The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
Ventegra, which provides drug benefit solutions, is also converting to a nonprofit status, which will be completed June 30, 2024.
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The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.
FDA officials are looking for additional information about the infusion device used to deliver apomorphine.
Caps on Medicare Part D cost sharing as a result of the Inflation Reduction Act, could reduce members’ financial incentive for switching to a biosimilar, suggests the newest Samsung Bioepis Quarterly Biosimilar Market Report.
The quality-adjusted life-years tool has been misunderstood, Dr. Joshua Cohen says. QALYs are a measure of the value that comes from restoring a person to health, not about discrimination.
Approved in late September 2022, Relyvrio will no longer be available for new amyotrophic lateral sclerosis (ALS) patients.
The FDA is also considering a separate BLA for a 2 mL syringe. Bimzelx is already available to treat plaque psoriasis as a 1 ml syringe; a dose is two subcutaneous injections with a cost of $7,200 per syringe.
Zevtera was approved to treat Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia.
Fanapt is now approved to treat adults acute manic or mixed episodes associated with bipolar I disorder. It is also available to treat schizophrenia.
Bacillus cereus contamination in Atovaquone Oral Suspension, which treats AIDS-related pneumonia, was found during stability testing at a third-party lab.
In 2025, the out-of-pocket cap and other Part D related provisions in the Inflation Reduction Act are projected to save women in Medicare an average of 28% in out-of-pocket costs, according to a new analysis from the Office of the Assistant Secretary for Planning and Evaluation.
Voydeya was approved for patients with paroxysmal nocturnal hemoglobinuria rare, progressive blood disorder that results in the developed of abnormal blood cells that are missing important proteins.
The recommended maximum daily dose of Vancomycin is up to 2 grams a day. The overfilled vials could result in patients receiving up to 4 grams a day.
Foluso Agboola discusses the framework that the Institute for Clinical and Economic Review has developed for assessing whether clinical trial populations represent the real-world patient population.
Vemlidy is now approved to treat patients 6 years and older with chronic hepatitis B virus infection.
Vafseo, an oral therapy to treat patients with anemia due to chronic kidney, will be available in January 2025. About 40% of patients who could be treated with Vafseo have coverage through Medicare Advantage plans.
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