FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

FDA Puts Hold on Gilead HIV Trials

Based on safety concerns, FDA places a clinical hold on Gileads HIV treatment trials of GS-1720, an investigational integrase strand transfer inhibito...

latest-news-card-1

OPDP Finds False, Misleading Addyi Post

The CDER Office of Prescription Drug Promotion warns Sprout Pharmaceuticals about a social media post for its Addyi that does not include any risk inf...

latest-news-card-1
FDA General

Contaminated Zicam and Orajel Lots Recalled

Due to contamination concerns, Church & Dwight recalls all lots of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething...

latest-news-card-1
Human Drugs

No IND for American Behavioral Study: FDA

FDA warns Boca Raton, FL-based American Behavioral Research Institute that it did not have an IND for a clinical study of Relaxium.

latest-news-card-1
Medical Devices

More Comprehensive AI Regulation Needed: Report

U.S. and Canadian AI researchers call on FDA to develop a more comprehensive regulatory framework for AI healthcare tools.

latest-news-card-1
FDA General

Makary/Prasad Priorities for A New FDA

FDA commissioner Martin Makary and CBER director Vinay Prasad use a JAMA article to list their five priorities for what they call a new FDA.

latest-news-card-1
Human Drugs

Promising Insmed Data in Pulmonary Arterial Hypertension

Insmed releases positive results from a Phase 2b clinical trial of its once-daily inhaled therapy treprostinil palmitil inhalation powder and its use ...

latest-news-card-1
FDA General

Former FDA Regulatory Counsel Lands at Alston & Bird

Former FDA regulatory counsel Jessica Ritsick joins Alston & Birds FDA practice in Washington, DC., after an 11-year career at the agency across numer...

Human Drugs

Innoviva NDA for Gonorrhea Antibiotic Accepted by FDA

FDA accepts for review an Innoviva Specialty Therapeutics NDA for zoliflodacin, an investigational first-in-class spiropyrimidinetrione oral antibioti...

latest-news-card-1
Human Drugs

Can Surprise Foreign Drug Inspections Boost Safety?

A MedShadow online post says President Trumps executive order to increase unannounced foreign drug inspections could help improve domestic drug manufa...