Ibogaine is drawing new interest from the Trump administration. Here’s what to know about the psychedelic

Psychedelic drugs, once pushed to the fringes of medicine, are gaining serious attention within the Trump administration as ...
TMCnet

NRx Pharmaceuticals Reports Positive FDA Office of Generic Drugs Feedback on Preservative-Free Ketamine Program

NRx has received a positive review letter (Discipline Review Letter) addressing Drug Quality requesting only “Minor” administrative changes NRx conducted a meeting with leadership of the FDA Office of ...
The White House

ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered: Section 1.  Purpose and ...

Moderna to Present Phase 1/2 Data on Its Investigational Cancer Antigen Therapy mRNA-4359 as First-Line Therapy in Combination with Pembrolizumab in Locally Advanced or ...

The U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of ...

Women can't get estrogen patches. Here's what the FDA is doing to help

Estrogen patches, one of the most popular menopause treatments, have been in short supply this year. Now the FDA is working ...
Becker's Hospital Review

5 FDA moves shaping drug development, oversight

FDA moves shaping drug development and oversight include new gene therapy guidance, clinical trial transparency efforts, and recent drug approvals.
FierceBiotech

FDA, NIH pledge more flexibility and $150M investment for animal testing alternatives

Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling an openness to new approaches that haven’t been validated and the National ...
FiercePharma

FDA rolls out new streamlined adverse event monitoring system, eyes $120M in savings

It’s out with the old, in with the new at the FDA as the agency is unveiling a new adverse events monitoring system that joins several reporting systems into one unified platform, an effort that’s ...
MedPage Today

So Long, MAUDE? FDA Launches New Combined Adverse Event Database

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...
Bloomberg L.P.

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 treatments for rare diseases, adding political pressure on an agency that’s ...
Wall Street Journal

FDA’s Controversial Vaccines Chief Will Leave the Agency

The Food and Drug Administration’s controversial vaccines chief is leaving the agency. Dr. Vinay Prasad, who has led the FDA’s vaccines and biotech drugs division, will depart at the end of April, FDA ...
CNBC

FDA reversals leave investors worrying about the fates of other experimental drugs

The FDA in the past year has denied or discouraged applications of at least eight new drugs, according to RTW Investments. The agency initially refused to review Moderna's flu shot before reversing ...