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FDA Wants Randomized Trial for Huntingtons Gene Therapy

[ Price : $8.95]

FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its ...

Merck Reports Promising Keytruda-Welireg Combo Data

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Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence o...

Takeda/Protagonist NDA Gets Priority Review for Polycythemia Vera

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FDA accepts for priority review a Takeda and Protagonist Therapeutics NDA for rusfertide, positioning the drug as a potential firs...

Pfizer CEO Concerned About FDA Vaccines Chief

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Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDAs biologics center is worrisome because it...

Intellia Gets Hold Lifted on MAGNITUDE Phase 3 Trial in ATTR-CM

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FDA removes a clinical hold against Intellia Therapeutics and its MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z), an expe...

Ex-FDA Leaders Accuse Trump Admin of Distorting Contraceptive Science

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Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contr...

FDA Employees Told Not to Use Claude AI in Tech Dispute

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HHS directs FDA and other health agency employees to immediately stop using the artificial intelligence platform Claude after the ...

Synergy Spines Artificial Cervical Disc Approved

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FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.

Researcher Critiques FDA Minimal Residual Disease Guidance

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A leading myeloma researcher says FDAs draft guidance endorsing minimal residual disease as a potential basis for accelerated drug...

User Fee Negotiations Are Hung Up on America First Proposals

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Drug user fee negotiators confront lingering divisions over FDAs America First proposals and the structure of hiring commitments, ...