Reuters21h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its ...
New FDA rules for TV drug ads: Simpler language and no distractions
The new rules, which cover both TV and radio, instruct drugmakers to use simple, consumer-friendly language when describing ...
Newsweek3h
FDA's New Rules Require TV Drug Ads to Be Clearer, More Direct
The FDA now requires drugmakers to use simple, consumer-friendly language when describing their medications. They are barred ...
Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
GlobalData on MSN1d
Intercept loses Ocaliva FDA full approval bid in rare liver disease
Intercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...
Yahoo15h
FDA says many cold medicines found over-the-counter don't work
The season of sniffling, sneezing and sinus trouble. But now the FDA is saying some decongeestants don't work. Dr. Justin ...
pharmaphorum12h
PTC gets FDA okay for first brain-delivered gene therapy
Kebilidi is the first gene therapy approved by the FDA for administration directly into the brain, given via a cannula during ...
GlobalData on MSN2d
FDA grants breakthrough status to J&J’s nipocalimab for SjD treatment
The US Food and Drug Administration (FDA) has awarded the second breakthrough therapy designation (BTD) to Johnson & ...
Autolus secures FDA approval for CAR-T cell therapy use in ALL
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy ...
FiercePharma4h
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...