FDA Related News

Human Drugs

Mural Oncology Scraps Nemvaleukin Alfa

Mural Oncology discontinues all clinical development of its lead drug candidate, nemvaleukin alfa based on disappointing results from two key trials i...

Medical Devices

FDA Authorizes Clicks Migraine Digital Therapeutic

FDA grants Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, a prescription digital therapeutic f...

Medical Devices

TytoCare Get Clearance for AI Lung Sound Device

FDA clears a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence-based device for detecting all three major abnorm...

Human Drugs

China Stricter than U.S. in Cancer Drug Approvals: Study

Chinese medical school researchers who analyzed cancer drug surrogate endpoint approvals in the U.S. and China say China appears to take a stricter ap...

Address Heart Failure Patient-Reported Outcome Issues

Researchers say some issues need to be resolved if patient-reported outcomes are to be used as a surrogate in heart failure drug and device trials.

Medical Devices

Recall All Humacyte Symvess Products: Petition

Citing concerns raised by a vascular surgeon when he was a CDRH medical reviewer, Harmed Americans for Reform in Medical Device Safety petitions FDA t...

Medical Devices

FDA Clears Bright Uros Urodynamics Device

FDA clears a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical ...

Human Drugs

Mirum Pharmaceuticals Livmarli Tablet Formulation OKd

FDA approves Mirum Pharmaceuticals tablet formulation of Livmarli (maralixibat) for treating cholestatic pruritus.

FDA General

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Human Drugs

Ironwood Needs Another Apraglutide Trial: FDA

Based on FDA recommendation, Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for apraglutide for treating short bowel syndr...