FDA Related News

Human Drugs

Hansa Biopharmas Imlifidase Hits Primary Endpoint

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

FDA NextGen Submission Portal Guide

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

FDA General

Public Confidence in FDA, Others Dropping: Survey

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

Human Drugs

Lillys Inluriyo OKd for Breast Cancer

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

Biologics

CBER Posts 13 FDA Form-483s

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

Medical Devices

Biolinq Gets De Novo for Glucose Sensor

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

Human Drugs

University of Texas Clinical Trial Issues

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

Human Drugs

Harmony Reports Disappointing Fragile X Data

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

Biologics

Cell/Gene Therapy Postapproval Monitoring Guide

FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gene therapy products a...

Biologics

Cellebration Refusing to Provide Records to FDA

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