News

RFK Jr. Says AI Will Approve New Drugs at FDA ‘Very, Very Quickly’
Kennedy Jr. appeared on the latest episode of Tucker Carlson’s podcast on Monday and it’s filled with the ramblings of a man ...
FDA probes deaths of boys taking Sarepta Duchenne drug
The FDA said yesterday that it is investigating the deaths from liver failure of two non-ambulatory boys with Duchenne ...
Bay Area family shares frustrations after FDA rejects drug for ultra-rare Barth Syndrome
With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is ...
Charles River Laboratories: FDA Regulation And High Debt Are Signs Of Headwinds
FDA's plan to phase out animal testing may hurt Charles River's revenues. The DCF model suggests that CRL presents an ...
American Kratom Association Applauds FDA Crackdown on Dangerous Chemically Manipulated 7-OH, Pseudoindoxyl and 'M' Products
Synthetic products posing as kratom mislead and endanger consumers; AKA urges FDA to take decisive action against violative ...
CURE17h
Therapies Which Received FDA Approval in July: What Patients Should Know
Breaking down what patients should know about each FDA therapeutic approval from June 2025 across various oncology ...
Family of Penn Hills officer who died by suicide after Lasik surgery receives letter from FDA
A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason. Now his ...
BioSpace22h
FDA Signs Off on Neurogene’s ‘Best-Case Scenario’ Pivotal Study Design for Rett Syndrome
The pivotal trial for Neurogene's Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that ...
Healio1d
FDA accepts new drug application for sublingual epinephrine film
The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...
FDA-approved drug may also treat alcoholism and withdrawal pain
A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity.
Olympus promises swift action after hardware blocked by FDA
Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its ...
STAT1d
Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.