Patients of all ages now have access to care for the rare genetic disease. The Food and Drug Administration (FDA) has announced approval for Itvisma (onasemnogene abeparvovec-brve), which…
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FDA Announces Recall of Shredded Cheese Due to Metal Contamination
Over 260,000 cases of shredded cheese have been recalled due to the potential for metal fragment contamination. The Food and Drug Administration (FDA) announced that Great Lakes Cheese…
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House Members Write to HHS and FDA Regarding Mail-Order Abortion Drugs
A request from 175 House Members follows an earlier Senate letter on safety protocols and oversight. A group of 175 members of the U.S. House of Representatives, led…
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USDA Launches Website to Centralize New World Screwworm Information
New federal portal centralizes information and updates on efforts to protect livestock and public health The U.S. Department of Agriculture (USDA) has recently introduced a new federal website…
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FDA Adds Warning and Restrictions to Duchenne Gene Therapy
Updated labeling limits treatment to ambulatory children after reports of fatal liver failure in non-ambulatory patients. The U.S. Food and Drug Administration (FDA) has approved significant labeling changes…
Read MoreFDA Places Restrictions on Ingestible Flouride Use
Companies must change their products to meet new standards after decades of unregulated use. The U.S. Food and Drug Administration (FDA) has restricted the use of fluoride-containing ingestible drug products…
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FDA Drafts New Guidance for the Development of Affordable Biosimilar Drugs
The new guidance seeks to lower development costs and improve patient access to safe, effective alternatives to high-cost biologic medicines. The U.S. Food and Drug Administration (FDA) recently…
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FDA Launches Voucher Program to Accelerate Priority Review of Drugs
Nine products selected under the pilot initiative are intended to address major health needs and boost U.S. manufacturing. The U.S. Food and Drug Administration has recently named nine…
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FDA Approves Drug for New World Screwworm in U.S. Livestock
Dectomax-CA1 receives conditional approval to help protect livestock from a serious parasitic threat while data collection continues. The U.S. Food and Drug Administration (FDA) has conditionally approved Dectomax-CA1…
Read MoreFDA Approves Second Generic Abortion Pill
HHS secretary states that federal regulations require the authorization of generics that are “identical to the brand-name drug.“ The Food and Drug Administration (FDA) approved a generic version…
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