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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...

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Human Drugs

Amneal Recalls Contaminated Tablets

Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to ...

Human Drugs

Arvinas Files NDA for Breast Cancer Drug

Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mu...

Medical Devices

FDA: Draeger Recall is Class 1

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

Human Drugs

ICH M11 Technical Specification Guidance Out

FDA publishes the International Council on Harmonization technical representation of its M11 guideline protocol template.

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Human Drugs

House Posts FDA Budget Mirroring Trumps Proposal

The House Appropriations Committee posts FDAs budget bill for FY 2026 that mirrors the Trump Administrations budget proposal that would decrease the a...

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Human Drugs

FDA Platform Technology OK for Sarepta Vector

FDA grants platform technology designation to a Sarepta viral vector used in an investigational gene therapy to treat a form of muscular dystrophy.