FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...

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 ...
KOSU

FDA reverses course on Moderna flu shot

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

FDA reverses course and will review Moderna’s mRNA flu shot, company says

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...

FDA chief Marty Makary says 'everything should be over-the-counter' unless drug is unsafe or addictive

Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.

FDA grants breakthrough status to Johnson & Johnson's cancer drug for advanced head and neck cancer

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a monotherapy for adults with advanced ...
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a possible treatment for autism symptoms, one of the largest studies examining its effectiveness in this population has been retracted.

FDA will drop two-study requirement for new drug approvals

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new ...

FDA reverses course and will review Moderna’s mRNA-based flu shot

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further studies. Federal officials did not immediately comment.