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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

Exec. Order Aims to Boost U.S. Biotech, Manufacturing

White House, Lafayette Square

An executive order issued by President Joe Biden yesterday seeks to make biotechnology and biomanufacturing a centerpiece of the American economy. . . . → Read More: Exec. Order Aims to Boost U.S. Biotech, Manufacturing

Infographic – U.S. Drug Prices vs. Other Countries

Chart: US and overseas drug prices

Rand Corporation published a study comparing U.S. drug prices to 32 other countries, and found U.S. residents pay on average 190 percent of the price paid elsewhere in the world. . . . → Read More: Infographic – U.S. Drug Prices vs. Other Countries

Trial Okayed for Engineered Cell Cancer Therapy

Tumor infiltrating lymphocyte

A clinical trial is set to begin testing engineered immune-system cells designed to precisely target and infiltrate cancerous tumors without other potentially toxic proteins. . . . → Read More: Trial Okayed for Engineered Cell Cancer Therapy

FDA Issues Action Plan for Rare Neuro Diseases

Man in wheelchair

The Food and Drug Administration published its blueprint to encourage new treatments for rare neurodegenerative disorders, including ALS. . . . → Read More: FDA Issues Action Plan for Rare Neuro Diseases