The Food and Drug Administration Monday unveiled the details of a new policy designed to make it easier and quicker for patients with very rare diseases to get cutting-edge treatments.
The new guidance would enable the agency to approve new treatments for rare diseases based on evidence for a "plausible mechanism" for how the treatment would work. The policy aims to speed the use of state-of-the-art technologies like gene-editing to create treatments tailored to individual patients suffering from diseases that are so rare that it would be difficult if not impossible to conduct a traditional study first.
"For decades families heard the same thing: There are not enough patients. The approval will take too long. You just have to wait for the science to catch up with your child, " Health and Human Services Secretary Robert F. Kennedy Jr. said at a briefing announcing the proposed new policy. "That ends today. Individualized medicine is no longer theoretical."




Last month, Colleen Fagan was observing an immigration enforcement operation at an apartment complex in Portland, Maine, when federal agents scanned her face with a smartphone and appeared to record her car license plate number.
Donald Trump’s decision to order airstrikes against Iran will hinge in part on the judgment of Trump’s special envoys, Steve Witkoff and Jared Kushner, about whether Tehran is stalling over a deal to relinquish its capacity to produce nuclear weapons, according to people familiar with the matter.
New Utah voting districts that give Democrats an improved shot at winning a US House seat can be used in this year’s election, a federal court ruled Monday while turning aside a Republican request to block the new map.
The U.S. Coast Guard launched an internal investigation after a swastika was found on a bathroom wall at a primary recruit training center in New Jersey.






























