US EditionUS FDA launches fresh safety scrutiny of approved RSV therapies for infants
The FDA is reviewing two monoclonal antibody treatments for infant RSV protection amid concerns raised by vaccine skeptics; these treatments reduced hospitalizations by up to 43%, CDC said.
- U.S. regulators are re-examining infant respiratory syncytial virus antibody treatments after vaccine skeptics raised concerns.
- The Centers for Disease Control and Prevention voted to rescind the universal recommendation for hepatitis B birth-dose vaccine for infants born to hepatitis B surface antigen-negative mothers.
- Drugmakers like Sanofi, AstraZeneca, and Merck were told their approved RSV therapies would face additional scrutiny due to safety inquiries initiated by FDA officials appointed under Robert F. Kennedy Jr.
82 Articles
82 Articles
FDA Analyzing Safety of RSV Antibodies Approved for Young Children
The Food and Drug Administration is reviewing the safety of antibodies against respiratory syncytial virus (RSV) that have been cleared for use in babies and toddlers. The probe is being conducted by the FDA’s Center for Drug Evaluation and Research (CDER), according to the government. “FDA routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence,” a spokesperson for the Depart…
US FDA launches fresh safety scrutiny of approved RSV therapies for infants
U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following concerns raised by vaccine skeptics, multiple sources familiar with the situation told Reuters.
FDA launches safety review of RSV infant drugs as RFK Jr. scrutinizes immunizations
The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations to face scrutiny under Health Secretary Robert F. Kennedy Jr. No safety issues have been reported with either of the respiratory syncytial virus drugs: Beyfortus, from Sanofi and AstraZeneca, and Enflonsia, from Merck. Andrew Nixon, a spokesperson at the Department of Health and Human Services, said in an emailed statemen…
Drugmakers Briefed As Vaccine Skeptics Like RFK Jr. Probe RSV Therapy Risks - AstraZeneca (NASDAQ:AZN), Merck & Co (NYSE:MRK)
U.S. regulators are reexamining infant RSV antibody treatments as safety questions surface, prompting new FDA scrutiny of products from major drugmakers.
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