FDA Related News

Medical Devices

MDUFA Small Business Qualification Guide

FDA publishes a guidance explaining the process it uses to determine and qualify a MDUFA small business.

Human Drugs

Vivace Mesothelioma Drug Gets Orphan Status

FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.

FDA General

House Dems Hit FDA, HHS Over Vaccines

Top House Democrats on the Energy and Commerce Committee raise alarm over what they describe as a coordinated effort by the Trump Administration to re...

Human Drugs

FDA Lays Out Unapproved GLP-1 Drug Concerns

FDA issues an online statement summarizing all its concerns with unapproved versions of GLP-1 weight loss drugs being marketed to U.S. consumers.

Human Drugs

AbbVie Seeks OK for All-Oral Leukemia Regimen

AbbVie files a supplemental NDA seeking approval for a new, fixed-duration, all-oral combination regimen of Venclexta (venetoclax) and acalabrutinib f...

Human Drugs

FDA Ends Arthritis Advisory Committee

FDA says its Arthritis Advisory Committee is no longer worth the effort and expense needed to maintain it, and it has been terminated.

Speed Access to Drugs and Cut Drug Use: Makary

FDA commissioner Martin Makary says he wants to find ways to get drugs to consumers faster, but also find ways to reduce the need for drugs by address...

Biologics

CBER Chief Prasad Fired, FDA Gold Standard Out Too?

Newly appointed CBER director Vinay Prasad abruptly leaves the agency after being attacked by Trump influencer Laura Loomer for expressing purportedly...

Biologics

Calidi Bio Gets Fast Track for Sarcoma Therapy

FDA grants Calidi Biotherapeutics fast-track status for CLD-201, an allogeneic stem-cell-loaded oncolytic virus being developed to treat soft tissue s...

Medical Devices

Multiple Violations at Onkos Surgical

FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medical device specificati...