Recall Impacts Exela and Civica Brands
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
Several Lots of Sandimmune Involved in Two Recall Efforts
Crystal formation observed Sandimmune Oral Solution (cyclosporine), which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.
Stability and Purity Issues Lead to Recall of Tydemy
One of the two recalled lots of the birth control tested high for a known impurity.
Subpotency Leads to Recall of 27 Lots of Tirosint-SOL
IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.
FDA Warns About Certain Compounded Semaglutide Products
The FDA has received adverse event reports after patients have used compounded semaglutide that contains salt formulations, which are different active ingredients than that used in the agency-approved drugs for diabetes and weight loss.
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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Trump Impact on Medicare Drug Price Negotiations Uncertain
Published: January 22nd 2025 | Updated: January 22nd 2025Trump has reversed some of President Biden’s initiatives, including $2 monthly out-of-pocket cap on some generics and experimental pricing models for gene therapies. But so far the healthcare elements of the Inflation Reduction Act remain unchanged.
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