The agency cited gaps in recall compliance during an investigation tied to infant formula botulism cases. The Food and Drug Administration (FDA) recently issued a reminder to food…
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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…
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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…
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President Announces TrumpRx Medication Program
He stated that purchasing from manufacturers directly will reduce prices. President Donald Trump announced a new program called TrumpRx this week under his Most Favored Nation (MFN) initiative,…
Read MoreFDA Begins Daily Updates of Adverse Drug Event Reports
The new reporting schedule is intended to improve transparency and speed in detecting safety concerns. The Food and Drug Administration has started publishing daily updates from the FDA…
Read MoreFDA Approves Ketamine Product for Surgical Pain Management
The agency says the psychedelic drug shows promise despite addictiveness and short supply. The Food and Drug Administration (FDA) approved a new ketamine-based drug called KETARx for use…
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FDA and USDA Propose Regulation Change for Orange Juice
The goal is to benefit U.S. citrus growers and reduce the reliance on foreign oranges for juice production. The U.S. Department of Agriculture (USDA) and the Food and…
Read MoreFDA Updates Opioid Labels to Emphasize Long-Term Risks
New labeling rules follow evidence linking extended opioid use to serious health dangers, including addiction and overdose. The U.S. Food and Drug Administration (FDA) has mandated updated safety…
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