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FDA General

FDA Budget Proposal Details $400 Million in Cuts

FDA releases its FY 2026 budget proposal showing that the agencys overall budget would decrease by 4% ($271 million) to $6.8 billion beginning 10/1.

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Human Drugs

Appeals Court Halts Federal Layoffs

A federal appeals court upholds a freeze on layoffs across FDA and other major federal agencies, rejecting an effort by the Trump administration to li...

Biologics

Moderna Wins OK for Next-Gen Covid Vaccine

FDA approves Modernas next-generation Covid-19 vaccine, Nexspike (mRNA-1283), for use in all adults 65 and older, and individuals aged 12-64 years wit...

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Human Drugs

Bipartisan Push Seeks Boost in ALS Research

Congressman Jason Crow (D-CO) leads a bipartisan group of lawmakers in a push to significantly expand federal funding for Amyotrophic Lateral Sclerosi...

Medical Devices

Improved Swoop Portable Brain MRI Cleared

FDA clears a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system.

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FDA General

FDA Launches Elsa AI Tool for Efficiencies

FDA launches a generative Artificial Intelligence tool called Elsa that is designed to help employees from scientific reviewers to investigators wor...

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Human Drugs

Enhertu Combo Delays Breast Cancer Progression

A new combination therapy involving AstraZeneca and Daiichi Sankyos Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentechs Perjeta) shows signifi...

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Human Drugs

Guide on Bioequivalence for Immediate-Release Drugs

FDA releases a draft guidance entitled M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.

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Human Drugs

Aurolife NC Drug Plant Hit With Form-483

FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP defic...

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Human Drugs

Group Seeks Warnings on Nuvigil, Provigil

Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy because they are allegedly l...