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Human Drugs

FDA Backs Jaguar on Cancer Diarrhea Drug Development

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

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Human Drugs

Pheast Gets Fast Track for Ovarian Cancer Drug

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

FDA General

RFK Jr. Fires 17 CDC Vaccine Committee Members

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

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Human Drugs

Mercks RSV Therapy Approved by FDA

FDA approves a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus lower respiratory tract disease in neonates and i...

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Human Drugs

FDA Rejects Axsomes Fibromyalgia Drug Application

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

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Human Drugs

Merck Reports Positive Data for PCSK9 Inhibitor Enlicitide

Merck touts promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PCSK9 inhibitor for us...

Biologics

Novavax Vaccine OK'd After Political Interference: JAMA

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

Medical Devices

Baxter Recalls Novum IQ Syringe Pump

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

Human Drugs

House Subcommittee Advances FDA Budget Bill

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

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Human Drugs

FDA OKs Petition to Correct Phathom Patent Listing

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