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Sen. Paul Introduces Biosimilars Bill

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U.S. senator Rand Paul (R-KY) introduces legislation to streamline the approval process for biosimilars by eliminating costly and ...

RFK Jr. Misfires at FDA Headquarters Address

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An address to FDA staff at the White Oak, MD campus by HHS secretary Robert F. Kennedy Jr. diverts to Deep State rhetoric and accu...

Daxor Files 510(k) for Next-Gen Blood Analyzer

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Daxor Corp. submits a 510(k) seeking FDA clearance for its next-generation blood volume analyzer.

Bipartisan Brain Cancer Research Bill In

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A bipartisan group of Senate and House members introduce legislation to advance research into brain cancer and improve care for br...

FDA to Phase Out Some Drug Animal Testing

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FDA says it intends to phase out animal testing in the development of monoclonal antibodies and some other drugs.

Biomedical Industry Seeks Senate Help on FDA Cuts

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Hundreds of U.S. biomedical innovators and investors urge the Senate to help restore critical FDA staff that were recently laid of...

J&J Reports Favorable Data on Psoriasis Drug

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Johnson & Johnson reports new icotrokinra (JNJ-2113) data from a Phase 3 studys subgroup analysis in moderate-to-severe plaque pso...

Information Bottleneck Due to FDA Staff Cuts: Analysis

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Two Hyman, Phelps & McNamara attorneys say reductions in staff at FDA are resulting in significant delays in agency responses to F...

FDA to Allow Some Teleworking: AP

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The Associated Press says FDA has reversed course and will permit some product reviewers and supervisors to work from home at leas...