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Wainua is approved to treat patients with hereditary transthyretin-mediated amyloid polyneuropathy and can be self-administered via an auto-injector.
The FDA has seized thousands of units of counterfeit Ozempic 1 mg.
This is the first treatment for patients with primary immunoglobulin A nephropathy to be granted full approval.
This is the second complete response letter for gefapixant, and FDA officials said the application did not provide evidence of effectiveness.
Nonprescription RiVive was approved in July 2023 to reverse opioid overdose. Harm Reduction is donating 200 doses to Remedy Alliance for distribution.
Outlook Therapeutics plans to begin a study in the first quarter of 2024 to address the issues identified in a FDA complete response letter. If approved, Lytenava would be the only bevacizumab product to specifically treat age-related macular degeneration.
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Filsuvez treats children and adults with epidermolysis bullosa, a condition that causes the skin to blister, and junctional epidermolysis bullosa, which causes lesions in the mouth.
In other generic news, the FDA has approved generics of the osteoporosis drug Forteo and Amneal is developing a generic version of Vascepa.
Zoryve foam will have the same wholesale acquisition cost as the cream version: $858 per tube.
The FDA cited issues related to an inspection of Checkpoint Therapeutics’ third-party contract manufacturing organization.
Additionally, the FDA has approved Avzivi — the fifth biosimilar that references the cancer drug Avastin.
The price for of Adbry is $1,810.87 for a two pack of syringes.
Welireg is now also indicated for patients whose renal cell carcinoma has progressed after treatment with PD-1 or PD-L1 inhibitor and a TKI therapy.
Zurzuvae has a list price of $15,900 for a 14-day course of treatment. No coverage information has been released.
The FDA has set a target date of June 12, 2024, for tarlatamab to treat adult patients with advanced small cell lung cancer. If approved, it would be the first bispecific antibody for a solid tumor.
Drug prices and the practices of PBMs are among the concerns expressed by employers who responded to the Pulse of the Purchaser survey by National Alliance of Healthcare Purchaser Coalitions.
The application for midomafetamine is the first NDA submission for any psychedelic-assisted therapy.
Optum Rx standard formularies currently include the weight loss drugs Wegovy and Saxenda, and the PBM is evaluating Zepbound.
Marstacimab is being reviewed to prevent or reduce the frequency of bleeding episodes in people with hemophilia A or B. The FDA has set an action date in the first quarter of 2024.
Eight of 10 drugs reviewed by Institute for Clinical and Economic Review were not supported by clinical evidence.
Cipla is recalling one lot of vigabatrin, which is used to treat seizures.
The FDA has approved the gene therapies Lyfgenia and Casgevy to treat patients with sickle cell disease. Casgevy is the first FDA-approved gene therapy to use the CRISPR gene editing technology.
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