The FDA cited issues with a third-party manufacturing company. Zolbetuximab is being reviewed to treat patients with stomach cancer.
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Zelsuvmi, a first-in-class topical treatment approved for patients with molluscum contagiosum, will be available in the second half of 2024.
Adam Fein, founder of Drug Channels, said the acquisition will allow the company to upgrade its technology, grow the company and provide live and in-person events.
If approved, Accord’s biosimilar would treat several autoimmune conditions and would be launched no later than May 15, 2025
CVS Caremark has entered into an agreement with AbbVie, the manufacturer of Humira, to supply Cordavis with Humira to develop a cobranded product. Cordavis is a CVS company developing private label therapies.
Zilbrysq has a list price $1,047.19 for a 23 mg syringe. It is UCB’s second treatment for patients with myasthenia gravis.
Loqtorzi has a wholesale acquisition cost of $8,892.03 per single-use vial.
The presence of glass can lead to serious adverse events, including inflammation of a vein and blockage of blood vessels or life-threatening blood clots.
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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.
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.
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