Tag

Clinical Benefit

All articles tagged with #clinical benefit

healthcare1 year ago•2 min saved

"Study: Accelerated Approval Fails for Many Cancer Drugs"

A study found that most cancer drugs granted accelerated approval by the FDA do not demonstrate clinical benefits within five years, raising concerns about patient access to unproven medications. Despite the program's intention to speed access to promising drugs, only 43% of the drugs demonstrated a clinical benefit in confirmatory trials, yet 63% were converted to regular approval. The study highlights the need for better communication of uncertainty to patients and the importance of careful explanation by doctors. Recent updates to the program give the FDA more authority to withdraw drugs when companies don't meet their commitments, aiming to streamline the process for verifying drug efficacy.

via NBC News|

#cancer-drugs #clinical-benefit #drug-efficacy

healthcare2 years ago•0 min saved

FDA Approves Sarepta Therapeutics' Gene Therapy for Duchenne Muscular Dystrophy.

The FDA has approved Sarepta Therapeutics' gene therapy treatment for children with Duchenne muscular dystrophy, despite questions about its clinical benefit.

via Barron's|

#clinical-benefit #duchenne-muscular-dystrophy #fda

health2 years ago•5 min saved

FDA advisers recommend approval of Alzheimer's drug Lecanemab.

An advisory panel for the US FDA voted unanimously that the Alzheimer’s drug lecanemab shows “clinical benefit” for the treatment of the disease, paving the way for the medication to be considered for full FDA approval. Lecanemab is one of the first dementia drugs that appears to slow the progression of cognitive decline. The drug is not a cure but works by binding to amyloid beta, a hallmark of Alzheimer’s disease. A decision from the FDA is expected by July 6.

via CNN|

#alzheimers #clinical-benefit #fda