FDA Related News

Human Drugs

Achelios Therapeutics Plans NDA for Topical Migraine Drug

Achelios Therapeutics says it is planning a 505(b)(2) NDA for Topofen (ketoprofen), a topical formulation of the non-steroidal anti-inflammatory drug ...

Federal Register

Comments Sought on Color Additive Certifications

Federal Register notice: FDA seeks comments on an information collection extension for Color Additive Certification Requests and Recordkeeping21 CFR P...

Human Drugs

Breakthrough Status for Omeros Monoclonal Antibody

FDA grants Omeros Corp. a breakthrough therapy designation for OMS721 for treating immunoglobulin A nephropathy.

Medical Devices

QS Violations in See Clear Inspection

The FDA Atlanta District Office warns The See Clear Company about Quality System violations in its work as a specification developer for daily-use sof...

Human Drugs

FDA Holding Public Meeting on Opioid Abuse Deterrence

FDA commissioner Scott Gottlieb announces a July 10-11 public meeting on the best way to evaluate the effectiveness of abuse-deterrent opioids.

Medical Devices

HHS Cybersecurity Task Force Report

The HHS Cyber Security Task Force lays out six imperatives with recommendations and action steps to addressing the increasing healthcare cybersecurity...

Human Drugs

Merck Pauses Keytruda Trial Enrollment to Study Deaths

Merck pauses new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring Keytruda (pembrolizumab) treatment in combination with other therapi...

Human Drugs

FDA Grants Duavee NCE Exclusivity

FDA grants five-year new chemical entity exclusivity to Pfizers Duavee, eliminating the need to respond to a company petition requesting that action.

Human Drugs

FDA Partnering with CancerLinQ on Treatment Use

FDA and CancerLinQ announce a long-term partnership to study real-world use of new cancer therapies.

Praise for Proposed FDA Office of Patient Affairs

Stakeholders praise FDA efforts to create a centralized Office of Patient Affairs.