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FDA approves Moderna COVID-19 vaccine for high-risk children

FDA approves Moderna COVID-19 vaccine for high-risk children

Moderna's Spikevax COVID-19 vaccine is now FDA-approved for all adults 65 and older and high-risk kids aged from 6 months to 11 years, aligning with new policy recommendations.

Medical groups sue RFK Jr. over COVID-19 vaccine policy shift

Medical groups sue RFK Jr. over COVID-19 vaccine policy shift

Medical groups are suing HHS Secretary Robert F. Kennedy Jr., alleging his removal of CDC vaccine guidance for kids and pregnant people without advisory input violates federal law.

Understanding the importance of randomized clinical trials

Understanding the importance of randomized clinical trials

Randomized controlled trials are the gold standard for proving therapeutic value, drug safety and efficacy, shaping pricing, reimbursement and securing regulatory approval.

FDA removes REMS for all autologous CAR T-cell immunotherapies

FDA removes REMS for all autologous CAR T-cell immunotherapies

The FDA has ended the Risk Evaluation and Mitigation Strategies safety program for six approved BCMA- and CD19-directed autologous chimeric antigen receptor T-cell immunotherapies.

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