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Human Drugs

Sen. Paul Introduces Biosimilars Bill

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

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FDA General

RFK Jr. Misfires at FDA Headquarters Address

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

Medical Devices

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

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

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Human Drugs

Bipartisan Brain Cancer Research Bill In

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

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Human Drugs

FDA to Phase Out Some Drug Animal Testing

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

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FDA General

Biomedical Industry Seeks Senate Help on FDA Cuts

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

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Human Drugs

J&J Reports Favorable Data on Psoriasis Drug

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

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FDA General

Information Bottleneck Due to FDA Staff Cuts: Analysis

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

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FDA General

FDA to Allow Some Teleworking: AP

The Associated Press says FDA has reversed course and will permit some product reviewers and supervisors to work from home at least two days per week.