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39 results for "fda approval"
After two decades of setbacks, scientists have achieved a major breakthrough with Lecanemab, the first fully approved treatment that actually slows Alzheimer's progression. Over 200 more potential treatments are now racing through clinical trials, bringing real hope to millions of families.
A heart condition once called a death sentence now has multiple FDA-approved treatments that are keeping patients alive and out of hospitals. Cardiac amyloidosis patients are being diagnosed earlier and living longer thanks to breakthrough medications approved in the past year.
A newly approved medication could help people with Prader-Willi syndrome control the constant, overwhelming hunger that defines their daily lives. One mother shares why she's hopeful this treatment will give her son Robert a chance at greater independence and happiness.
The FDA just made it easier for millions of Americans with rare diseases to access life-saving gene therapies without waiting years for traditional clinical trials. Families who were told to "wait for science to catch up" now have real hope.
For the first time in three decades, patients with inoperable pancreatic cancer have a new treatment option. The FDA just approved Optune Pax, a wearable device you use at home that uses electric fields to kill cancer cells.
Patients with chronic lymphocytic leukemia now have a new treatment option that doesn't require chemotherapy and allows time off from treatment. The FDA approved the first all-oral, fixed-duration therapy for this common adult leukemia.
Millions living with serious mental illness just got a new treatment option. The FDA approved Bysanti, offering hope for those managing bipolar 1 disorder and schizophrenia.
The FDA just approved BYSANTI, a new medication offering hope to millions of Americans living with schizophrenia and bipolar I disorder. Built on more than a decade of proven safety data, this treatment represents a faster path to innovation in mental health care.
A promising new liver cancer treatment just received FDA Fast Track designation, potentially speeding up access for patients who need it most. The designation for PLT012 marks meaningful progress in the fight against one of the deadliest cancers.
A tongue-stimulating mouthpiece just got FDA approval to treat the phantom ringing that affects 25 million Americans. Clinical trials show 91% of users experienced major relief from their tinnitus symptoms.
After an unexpected rejection last week, the FDA has reversed course and agreed to review Moderna's new mRNA flu vaccine. Seniors could have a new option to protect against the flu by late 2026.
After rejecting Moderna's flu vaccine application just a week ago, the FDA reversed course and will now review the promising mRNA shot. The new technology could revolutionize how we protect ourselves from seasonal flu.
A groundbreaking depression treatment using psilocybin is showing promising results in clinical trials, potentially becoming the first psychedelic therapy approved by the FDA. Two major studies confirm the compound helps patients with severe depression find relief.
After three decades without new options, patients with locally advanced pancreatic cancer now have access to a wearable device that extends life and reduces pain. The breakthrough treatment adds two months of survival time while maintaining quality of life.
Surgeons can now track spinal movement in real time during surgery thanks to a newly cleared robotic system that combines planning, navigation, and execution in one platform. The technology aims to make complex spine procedures more precise and predictable for millions of patients.
Patients with one of the deadliest forms of colorectal cancer are living more than twice as long thanks to a breakthrough treatment that just earned FDA Fast Track status. The therapy is showing remarkable results in cancers that resisted everything else doctors could throw at them.
Patients with one of the deadliest cancers can now use an electric field device at home alongside chemotherapy. The wearable patches add two months of survival time without the harsh side effects of traditional treatments.
For the first time in three decades, the FDA has approved a new treatment for locally advanced pancreatic cancer that extends survival and reduces pain. The wearable device uses electric fields instead of drugs to target cancer cells.
The FDA just approved Optune Pax, a new treatment option for people battling locally advanced pancreatic cancer. This approval brings fresh hope to patients facing one of the most challenging cancer diagnoses.
A breakthrough medical device that delivers life-saving therapies directly into the heart just cleared a major regulatory hurdle. The technology could transform treatment for millions living with heart failure.
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