Healthy returns: FDA chief Marty Makary on compounded GLP-1s, vaccines and China

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and ...
STAT

In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy

The top drug regulator at the FDA told staff she plans to question the safety of taking SSRIs in pregnancy and of RSV shots ...

Cat food sold in 10 states, including Oregon, recalled after report of pet illness

Cat food sold across 10 states, including Oregon, was recalled after at least one customer reported a linked illness in their ...

FDA chief warns US is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis

PureTech Announces Orphan Drug Designations Granted by the U.S. Food and Drug Administration and European Commission for Deupirfenidone in IPF ...
Disability Scoop

Autism Study Of Drug Touted By Trump Administration Retracted

Months after Trump administration officials hyped a drug as a possible treatment for autism symptoms, one of the largest studies examining its effectiveness in this population has been retracted.

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics ...

Industry Urged to Strengthen HACCP Training and FSVP Training Amid Declining USDA & FDA Inspection Capacity

Watchdog groups report that while the number of regulated facilities has increased, the volume of inspections has ...

Houston-based distributor tied to FDA peanut butter recall affecting 40 states

A nationwide peanut butter recall affecting more than 23,000 cases of product distributed in Texas and 39 other states ...