Current drug shortages based on FDA data, prepared by Formulary Watch.
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Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
When Medicare D plans do provide coverage for first generics, they are often placed on non-generic tiers.
The June 30 approval meets an unmet need in this cancer.
The accreditation is effective through July 2024.
The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.
The therapy is approved for both adults and children.
Azstarys is approved to treat patients 6 years and older.
Most of the suspected cases of myocarditis developed after the second dose of the vaccine and were among younger males.
Wynzora is a cream-based, fixed dose combination of calcipotriene and betamethasone for topical treatment of psoriasis.
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This is being done in coordination with the FDA to address the shortage created by the recall of Chantix. UPDATE: Pfizer has expanded its recall of Chantix from nine lots to 12 lots.
The company’s stock began dropping on Tuesday with analyst expectation the FDA will issue a Complete Response Letter for tenapanor, its chronic kidney disease therapy.
Eight out of 10 covered U.S. commercial lives now have access to the H. pylori therapy.
This research sought to understand the relationship of prior medication exposure, existing health conditions, and COVID-19 outcomes using data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry.
Vaxneuvance is approved for 15 serotypes, including those that are major causes of disease.
Current drug shortages based on FDA data, prepared by Formulary Watch.
FDA staff raised safety concerns ahead of the advisory panel hearing.
Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.
The first generic of the high-dose intravenous iron, a generic of Feraheme, is now available.
Committee members raised safety concerns about FibroGen/AstraZeneca’s oral therapy roxadustat.
Several large payers are waiting on results from the National Coverage Determination.
After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.
New analysis suggests that even with rebates, the new Alzheimer’s therapy could have implications for Medicaid drug spending.
An FDA inspection of compound pharmacy Innoveix Pharmaceuticals indicated these lots may not be sterile.
A permanent code is expected in the third quarter of 2021.
The first generic equivalent of the HIV therapeutic is now available.
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