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…
Read MoreMedication
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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President Trump Plans New Tariffs for Several Industries
The president highlights the compromising of national security by foreign trade practices and the need to protect U.S. manufacturing from “unfair outside competition.“ President Donald Trump announced a…
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Former President Biden Undergoes Mohs Surgery
Physicians check the skin for cancer resurgence after his prostate cancer diagnosis was announced in May. Former President Joe Biden recently underwent Mohs surgery to test for the…
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…
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Eighth Circuit Court Upholds Arkansas Ban on Transgender Interventions for Minors
The panel stated that the law regulates medical procedures without discrimination. The Eighth Circuit Court of Appeals upheld an Arkansas law last week that bans transgender procedures and…
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FDA 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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HHS Secretary and CMS Administrator Commit to Prior Authorization Reforms
They announced major private-sector pledges to reduce delays and burdens in health coverage approvals. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and Centers for Medicare…
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FDA Expands Approval for RSV Vaccine for Adults Under 60
Without a CDC director, the approval depends on the HHS secretary to endorse it. The Food and Drug Administration (FDA) approved the use of Moderna’s Respiratory Syncytial Virus…
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