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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.

Human Drugs

Jubilant HollisterStier CGMP Issues

FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.