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723 results for "** fda"
Three psychedelic treatments for depression and PTSD could receive FDA approval as soon as this summer, potentially offering hope to millions struggling with mental health conditions. The accelerated review process cuts approval time from a year down to just weeks.
The FDA approved leucovorin for cerebral folate deficiency, a rare genetic brain disorder affecting fewer than one in a million people. The decision brings clarity after months of confusion about the drug's potential uses.
Americans will finally get access to a sunscreen ingredient Europe has used for decades, ending a 25-year gap in product innovation. The FDA's approval of bemotrizinol marks a major shift toward faster approval of safe, effective products.
The FDA is accelerating breakthrough psychedelic therapies for treatment-resistant depression, PTSD, and alcohol use disorder after a presidential directive. Veterans and millions struggling with serious mental illness could gain access to promising new options backed by rigorous science.
After surprising companies with a rejection in January, the FDA has agreed that existing trial data for a rare blood cancer therapy is sufficient for approval review. The agency's reversal gives new hope to patients with limited treatment options.
The FDA just unveiled a new approval process that could bring life-saving treatments to millions of Americans with rare diseases in months instead of years. Families who've heard "wait for the science to catch up" finally have reason to hope.
Wearable fitness tracker Whoop resolved a year-long dispute with federal regulators, opening the door for more personal health data to reach consumers. The FDA ended enforcement action after the company tweaked how its blood pressure feature works. #
A new FDA pathway could cut the time to get personalized CRISPR treatments from four years to just three months, making life-saving gene editing accessible to thousands of children born with rare genetic diseases. Baby KJ Muldoon became the first person to receive this revolutionary treatment in February 2025.
The FDA just launched two groundbreaking clinical trials that send safety data to regulators instantly, cutting years from the drug approval process. For patients waiting on life-saving treatments, this could change everything.
The FDA just gave breakthrough status to the first generative AI chatbot designed to guide patients through recovery after joint replacement surgery. The move signals how AI could soon help millions of people heal better at home.
The FDA suddenly agreed to review Moderna's revolutionary mRNA flu vaccine after initially rejecting it just a week earlier. Meanwhile, scientists developed an inhaled vaccine that could protect against multiple respiratory illnesses at once.
The FDA just announced a new pathway that could bring life-saving gene editing treatments to patients with rare diseases in record time. For families battling conditions once considered untreatable, this could change everything.
The FDA just gave breakthrough status to its first generative AI chatbot for patients recovering from joint replacement surgery. This marks a major step forward in how artificial intelligence could help millions heal at home.
The U.S. government just launched major initiatives to phase out animal testing in drug development, backing new methods that better simulate human biology. The FDA released new guidance while the NIH committed over $150 million to institutions pioneering alternatives.
The FDA just unveiled a breakthrough framework that could bring life-saving gene therapies to thousands of children with rare diseases in a fraction of the time. For families who've watched their kids suffer while treatments stall, this changes everything.
The FDA just announced a revolutionary approach that could cut years off the time it takes new treatments to reach patients. For the first time, regulators will monitor clinical trials as they happen, watching results unfold in real time instead of waiting months for reports.
The FDA just created a faster pathway for patients with rare genetic disorders to access personalized gene therapies without lengthy clinical trials. While some experts celebrate this breakthrough for desperately ill patients, others urge caution about adequate safety monitoring.
Families battling ultra-rare diseases just got a major breakthrough: the FDA announced a new pathway that will speed life-saving treatments to patients who've been told for decades "there aren't enough of you to study." A baby boy's miraculous CRISPR therapy inspired the change.
A groundbreaking gene-editing treatment could reach patients faster than ever before, as Prime Medicine asks the FDA to approve their therapy after just two successful treatments. The drug uses a revolutionary CRISPR technique to fix a genetic disorder that leaves patients vulnerable to deadly infections.
Americans finally get access to bemotrizinol, a superior sunscreen ingredient that's been protecting skin in Europe and Asia for years. The FDA approval closes a two-decade gap in sun protection options.
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