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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...

Capricor Gets FDA OK on Duchenne BLA Refiling

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Capricor Therapeutics reaches agreement with FDA on the design and role of its HOPE-3 trial as it works to resubmit its BLA for De...

Hansa Biopharmas Imlifidase Hits Primary Endpoint

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Hansa Biopharma says imlifidase met the primary endpoint in a pivotal Phase 3 study in kidney transplant patients.

FDA NextGen Submission Portal Guide

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FDA publishes a guide to its Electronic Submission Gateway NextGen Unified Submission Portal.

Public Confidence in FDA, Others Dropping: Survey

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The latest University of Pennsylvania Annenberg Public Policy Center survey documents a significant drop since last fall in the pe...

Lillys Inluriyo OKd for Breast Cancer

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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...

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...