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168 results for "fda approval"
A new combination therapy for aggressive prostate cancer just got FDA approval, along with two tests that help doctors match the right patients to this targeted treatment. This breakthrough could help up to 30% of men with advanced prostate cancer find a treatment plan designed specifically for their genes.
After losing an 11-month-old patient in 1985, neurosurgeon Kevin Tracey spent 40 years developing a tiny implant that tames deadly inflammation. The FDA just approved his device for 1.5 million Americans with rheumatoid arthritis.
A revolutionary drug just doubled survival time for patients with advanced pancreatic cancer, one of the deadliest forms of the disease. Doctors are calling it unprecedented, and the breakthrough could soon help patients with lung, colorectal, and other cancers too.
A new drug has functionally cured chronic hepatitis B in one in five patients, offering hope for the 254 million people living with the world's most common liver infection. The FDA is expected to decide on approval by October 2026.
An experimental pancreatic cancer treatment that helped patients live nearly twice as long as standard chemotherapy is now reaching patients before formal FDA approval. Revolution Medicines began shipping daraxonrasib to physicians this week through a special early access program.
A breakthrough medication called bepirovirsen has functionally cured 20% of chronic hepatitis B patients within one year, marking the first major treatment advance in decades. The FDA is expected to decide on approval this October.
A groundbreaking treatment that could prevent PTSD before it takes hold just cleared a major regulatory hurdle. The FDA has approved human trials for RST-101, a drug designed to stop trauma from becoming chronic psychological distress.
The FDA just approved a new treatment for adults with blastic plasmacytoid dendritic cell neoplasm, an extremely rare and aggressive blood cancer. This marks new hope for patients facing a disease with very few treatment options.
A simple blood test from Singapore just earned breakthrough status from the FDA for detecting 10 types of cancer early. The test has already screened over 100,000 people in Asia with promising results.
A once-daily pill for sleep apnea is advancing through FDA review after clinical trials showed it reduced breathing disruptions by 44 percent. The experimental drug could offer hope to millions who struggle with CPAP machines, though doctors urge realistic expectations.
A newly approved ALS treatment can now target specific genetic causes of the disease, offering hope to patients with Lou Gehrig's disease. The FDA fast-tracked the therapy, marking a significant breakthrough in personalized medicine for neurological conditions.
Three breakthrough breast cancer medications can now be used in earlier disease stages, giving patients better survival rates with fewer side effects. The drugs previously reserved for late-stage cases are now available for stage two and three patients.
A rice-sized implant with living cells is now FDA-approved to slow vision loss in MacTel patients, offering hope to thousands losing their sight. For the first time, people with this rare retinal disease have a real chance to preserve their independence.
A breakthrough medication could become the first FDA-approved treatment designed specifically for children with Tourette syndrome, reducing tics by 50% without the harsh side effects of current drugs. After a successful Phase III trial across 77 sites, the drug ecopipam is heading for FDA review.
A new FDA-approved device uses gentle sound waves to break kidney stones into tiny fragments without anesthesia or damaging tissue. The breakthrough could move kidney stone treatment from operating rooms to doctor's offices.
Women with triple negative breast cancer now have a powerful new treatment option that nearly doubles the time before their disease progresses. The FDA just approved Datroway, giving hope to patients who previously had limited choices beyond traditional chemotherapy.
A new nightly pill reduced sleep apnea episodes by 44% in clinical trials, offering hope to nearly 1 billion people worldwide who struggle with the condition. The FDA has fast-tracked approval, with a decision expected in 2027.
After years without any approved therapies, adults living with chronic hepatitis delta virus now have hope with the FDA's approval of Hepcludex, the first treatment for one of the most severe forms of viral hepatitis. This breakthrough fills a critical gap for nearly 200,000 Americans who face rapid progression to serious liver complications.
Millions who can't tolerate CPAP machines may soon have a once-nightly pill that treats the neuromuscular cause of obstructive sleep apnea. In a major trial, 40% of patients saw their disease severity drop, and nearly one in five achieved complete control.
A groundbreaking medication just moved closer to FDA approval after helping trial participants lose an average of 70 pounds in 80 weeks. The drug matches results typically seen only with surgery, offering new hope for millions struggling with obesity.
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