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FDA General

Administration Weighs White House Aide for FDA Top Post

The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.

Biologics

JAMA Publishes Previously Blocked Covid-19 Vaccine Study

JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...

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FDA FY 2027 Appropriation Report Analyzed

Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectations for the FY 2027 ...

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Human Drugs

FTC Weighs in Against J&J in Stelara Monopoly Case

The Federal Trade Commission files an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unlawfully maintaining ...

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Human Drugs

FDA Details Standardized Approach to Drug Safety Signal Detection

A new CDER Office of New Drugs webinar discusses the development and use of OND Custom Medical Queries to identify potential safety signals during rev...

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Medical Devices

Require IDE for Venas MicroAngioscope: Petition

Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena MicroAngioscope and take other steps to determine if...

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FDA General

FDA Making Good Progress Hiring New Staff: Zeta

Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attrition as signs of an...

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Human Drugs

JAMA Revisits FDA's Controversial OK of Depression Drug Gepirone

A new analysis published in JAMA Psychiatry raises fresh questions about how FDA evaluates drug efficacy when clinical trial results are mixed, using ...

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EIRS/483s

FDA Expands Ibrance for Breast Cancer Maintenance

FDA grants Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance...

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Human Drugs

Drug Trial Demographic Info Reported

FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.