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Biotech Group Blasts Reproductive Drug Ruling

Mifeprex boxes

A biotechnology industry group calls Friday’s ruling in a Federal district court to suspend approval of the drug mifepristone “an assault on science.” . . . → Read More: Biotech Group Blasts Reproductive Drug Ruling

Trial Okayed for Glaucoma Treatment Implant

Fundus photograph

A developer of treatments for eye diseases says it received clearance from FDA to begin a clinical trial of a sustained-release implant therapy for glaucoma. . . . → Read More: Trial Okayed for Glaucoma Treatment Implant

PCORI Funds Personal Dialysis Model Assessment

Kidney illustration

A team from an academic medical center and research institute are evaluating a personalized dialysis model for people with kidney disease, but with still some kidney functions. . . . → Read More: PCORI Funds Personal Dialysis Model Assessment

Panel: A.I. Regulation Needed, But Long Way Off

Emma Pierson at AAAS meeting

A panel of data scientists at a professional meeting says artificial intelligence needs more rigorous oversight, but many questions remain on who and how to do the regulating. . . . → Read More: Panel: A.I. Regulation Needed, But Long Way Off

Over-the-Counter Naloxone Receiving Faster FDA Review

Nasal spray

The opioid overdose drug naloxone in nasal spray form is receiving priority review from the Food and Drug Administration as an over-the-counter drug. . . . → Read More: Over-the-Counter Naloxone Receiving Faster FDA Review

FDA Clears AI Heart Failure Detection System

Digital heart health graphic

The Food and Drug Administration authorized for marketing an algorithm-driven medical device for diagnosing a common, but difficult to detect, type of heart failure. . . . → Read More: FDA Clears AI Heart Failure Detection System

FDA Clears Digital Health Monitoring System

EmbracePlus device

A developer of remote health tracking technology says the Food and Drug Administration cleared its continuous patient monitoring system for clinical use. . . . → Read More: FDA Clears Digital Health Monitoring System

Company to Boost Orphan Drugs in Europe

Europe at night from space

A start-up enterprise seeks to make drugs for treating rare diseases more readily available to physicians and patients in Europe. . . . → Read More: Company to Boost Orphan Drugs in Europe

RSV Nose Drops Vaccine Gets FDA Fast Track Tag

Respiratory syncytial virus

A vaccine designed from engineered live viruses and taken as nose drops to prevent respiratory syncytial virus received a Food and Drug Administration fast-track designation. . . . → Read More: RSV Nose Drops Vaccine Gets FDA Fast Track Tag

FDA Clearance Requested for Behavioral Diabetes Therapy

Blood glucose test

A digital health company is asking for FDA authorization to market a mobile app that helps treat type 2 diabetes with cognitive behavioral therapy. . . . → Read More: FDA Clearance Requested for Behavioral Diabetes Therapy