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Self-Inject Vyvgart Hytrulo Approved

[ Price : $8.95]

FDA approves an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and h...

Fast Track for H5N1 Flu mRNA Vaccine

[ Price : $8.95]

FDA grants Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, for protectin...

FDA OKs Opdivo + Yervoy in Liver Cancer

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FDA approves Bristol Myers Squibbs Opdivo (nivolumab) and Yervoy (ipilimumab) for combination first-line treatment of adult patien...

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.

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...

Alzheon Alzheimers Trial Misses Primary Endpoint

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Alzheon says its Phase 3 valiltramiprosate trial in early Alzheimers disease patients did not meet its primary endpoint of slowing...