FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CeleCor Completes NDA Submission for Heart Attack Drug

[ Price : $8.95]

CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevatio...

Drug Quality Assurance Inspections Up in 2025

[ Price : $8.95]

The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.

FDA Progressing Toward Replacing Animal Testing :Study

[ Price : $8.95]

A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is...

Antibody Impurity Guidance Needs Specificity: Comments

[ Price : $8.95]

Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.

Stakeholders Comment on AI-Enabled Trial Pilot

[ Price : $8.95]

Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.

FDA Making Good Progress Hiring New Staff: Zeta

[ Price : $8.95]

Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attr...

JAMA Revisits FDA's Controversial OK of Depression Drug Gepirone

[ Price : $8.95]

A new analysis published in JAMA Psychiatry raises fresh questions about how FDA evaluates drug efficacy when clinical trial resul...

FDA Expands Ibrance for Breast Cancer Maintenance

[ Price : $8.95]

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

Drug Trial Demographic Info Reported

[ Price : $8.95]

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

Administration Weighs White House Aide for FDA Top Post

[ Price : $8.95]

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