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RFK Jr. Fires 17 CDC Vaccine Committee Members

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HHS secretary removes all 17 members of the CDCs Advisory Committee for Immunization Practices (ACIP), and plans to appoint new me...

Mercks RSV Therapy Approved by FDA

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FDA approves a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus lower respiratory tract disea...

FDA Rejects Axsomes Fibromyalgia Drug Application

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Citing an inadequate clinical trial, FDA refuses to file an Axsome NDA for its fibromyalgia drug AXS-14 (esreboxetine).

Merck Reports Positive Data for PCSK9 Inhibitor Enlicitide

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Merck touts promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PC...

Novavax Vaccine OK'd After Political Interference: JAMA

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A JAMA viewpoint article raises alarms about FDAs full approval last month of Novavaxs Covid-19 vaccine and the agencys unusual de...

Baxter Recalls Novum IQ Syringe Pump

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Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the devices...

House Subcommittee Advances FDA Budget Bill

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A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committe...

FDA OKs Petition to Correct Phathom Patent Listing

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FDA approves a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize 10 years of new c...

Amneal Recalls Contaminated Tablets

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Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their ta...

Arvinas Files NDA for Breast Cancer Drug

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Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor recepto...