The FDA is requesting an additional study to demonstrate tenapanor lowers serum phosphorus.
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Drugs that provide only incremental benefit may not be included on clinical pathways.
The approval allows for substitution at the pharmacy counter for Lantus, its reference product.
The agency has stopped enrollment in all ongoing trials.
The findings were similar in people with or without diabetes.
Competition among branded products did not substantially curb annual spending increases.
A substantial discount would be needed to meet cost-effectiveness thresholds.
The FDA would like to see additional data on clinical benefit for patients with anal cancer.
Angiotensin receptor blockers may be less likely to cause side effects than ACE inhibitors.
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.
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.
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