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FDA Backs Jaguar on Cancer Diarrhea Drug Development

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Jaguar Health plans to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea in breast cancer patients after g...

Pheast Gets Fast Track for Ovarian Cancer Drug

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As it heads into a Phase 1 study, FDA grants Pheast Therapeutics a fast-track designation for PHST001 and its use in treating pati...

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...

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...

FDA: Draeger Recall is Class 1

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FDA says a Draeger recall of breathing circuit components is Class 1.