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Lillys Inluriyo OKd for Breast Cancer

[ Price : $8.95]

FDA approves an Eli Lilly NDA for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist for treating certa...

CBER Posts 13 FDA Form-483s

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CBER posts 13 Form FDA-483s under the Freedom of Information Acts provision on frequently requested records.

Biolinq Gets De Novo for Glucose Sensor

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FDA grants Biolinq a de novo authorization for its Shine system, said to be the first fully autonomous, needle-free glucose sensor...

Kennedy, Makary Pledge Mifepristone Review

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HHS secretary Robert F. Kennedy, Jr., says FDA is reviewing safety evidence relating to the medication abortion drug mifepristone.

FDA Ends Caprelsa REMS

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FDA says the Risk Evaluation and Management Strategy program that has been in place since 2011 for Sanofis thyroid cancer drug Cap...

University of Texas Clinical Trial Issues

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FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of ...

Harmony Reports Disappointing Fragile X Data

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Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not m...

Cell/Gene Therapy Postapproval Monitoring Guide

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FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gen...

Cellebration Refusing to Provide Records to FDA

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FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency re...

Acadias Phase 3 Trial of Intranasal Carbetocin Fails

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Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for tre...