FDA Related News

ASCO Reaches Out to FDA, NIH, CMS

The Association for Clinical Oncology tells the new leaders of FDA, NIH, and CMS it looks forward to working with them on behalf of cancer research an...

Human Drugs

Cobenfy Effective as Schizophrenia Adjunct: Trial

Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antipsychotics for patien...

Human Drugs

Update Drug Labels with Obesity Info: Pitts

Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness information.

Human Drugs

Lilly Sues 4 More Weight-Loss Drug Compounders

Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.

Medical Devices

Alert Issued on Conavis Novasight Catheters

The catheter is part of a system intended for intravascular imaging of coronary arteries.

Biologics

FDA Seeks Post-Marketing Commitment from Novavax

Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

Medical Devices

CereVasc Gains Breakthrough Status for eShunt

FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus.

FDA General

ESG NextGen is Live: FDA

FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.

Human Drugs

Vanda Criticizes FDA on Tradipitant Hearing Delay

Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a company request for a hea...

Human Drugs

Akesos Ivonescimab Meets Endpoint in Lung Cancer

Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung c...