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.

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...

Human Drugs

Acadias Phase 3 Trial of Intranasal Carbetocin Fails

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

Biologics

Regenerative Therapies Expedited Programs

FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for serious conditions.

Biologics

CGT Trial Innovative Designs Guidance

FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to support licensure o...