Republican launches investigation into Trump admin FDA denials

"The stories are so outrageous," Senator Ron Johnson said. "It just appears that they’re looking for excuses to say no." ...

FDA official calls UniQure's gene therapy a 'failed' treatment for Huntington's disease

UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.
BioSpace

Makary Defends FDA’s Decision-Making Amid Contentious Rare Disease Rejections

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically ...

FDA goes on offense amid surge of criticism for recent drug decisions

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug ...
STAT

FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad

FDA Commissioner Marty Makary defended the agency’s recent rejections of rare disease drugs and one of his deputies, Vinay ...
Yahoo

Extended interview: FDA chief calls warnings on menopause treatments an "American tragedy"

Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Dr. Marty Makary tells CBS News' Norah O'Donnell in an exclusive interview why the agency decided to drop decades ...

Key US senator investigates FDA over rare-disease drug denials

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of ...
Bloomberg L.P.

FDA Is Looking for Expanded Power to Crack Down on Illegal Vapes

The Food and Drug Administration is taking a closer look at kratom extracts and preparing to ask Congress for expanded authority to shut down illegal vaping imports, according to the agency’s head. In ...
Applied Clinical Trials Online

FDA Support Drives Shift Toward Bayesian Trial Design

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...
BioPharma Dive

UniQure says FDA wants another study of Huntington’s gene therapy

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.
Targeted Oncology

Key Considerations for the FDA’s Guidance on MRD End Point in Myeloma

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...
BioSpace

FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle ...