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Neuro Device Shown to Relieve Adolescent Migraine Pain

Nervivo device and app

Findings from a clinical trial show a wearable device sending electronic signals into the nervous system relieves migraine pain in children age 12 to 17. . . . → Read More: Neuro Device Shown to Relieve Adolescent Migraine Pain

Covid-19 Antibody Developer Raises $483M in IPO

Wall Street sign

A biotechnology company developing therapeutic antibodies for Covid-19 infections is raising $483 million in its initial public offering of common stock. . . . → Read More: Covid-19 Antibody Developer Raises $483M in IPO

FDA Begins Qualifying Non-Animal Testing Options

Lab mouse

The Food and Drug Administration began a pilot program for assessing alternative technologies to test drugs, biologics, and devices without animals. . . . → Read More: FDA Begins Qualifying Non-Animal Testing Options

Univ, Industry Labs Study Inhaled Covid-19 Antibodies

Adeno-associated virus

Researchers at University of Pennsylvania and Regeneron are studying delivery of synthetic antibodies directly to the nose to prevent Covid-19 infections. . . . → Read More: Univ, Industry Labs Study Inhaled Covid-19 Antibodies

Trial Requested for Covid-19 Vaccine Nasal Spray

Nasal spray

Makers of a Covid-19 vaccine given as a nasal spray asked the Food and Drug Administration to authorize a a human clinical trial of the vaccine. . . . → Read More: Trial Requested for Covid-19 Vaccine Nasal Spray

Stem Cell Respiratory Therapy Licensed in $1.4B Deal

Inspecting lung X-rays

Global drug maker Novartis is acquiring a stem cell-based treatment for a serious respiratory disease associated with Covid-19 infections. . . . → Read More: Stem Cell Respiratory Therapy Licensed in $1.4B Deal

FDA Grants Emergency Clearance for Home Covid-19 Test

Lucira test

The Food and Drug Administration gave an emergency authorization for a self-collected Covid-19 diagnostic test, the first such test for home use. . . . → Read More: FDA Grants Emergency Clearance for Home Covid-19 Test

ALS Stem Cell Therapy Fails to Meet Trial Objective

Neurons

Clinical trial results of an amyotrophic lateral sclerosis, or ALS, therapy do not show slower disease progression among patients compared to a placebo. . . . → Read More: ALS Stem Cell Therapy Fails to Meet Trial Objective

Covid-19 Saliva Test Earns FDA Emergency Clearance

SARS-Cov-2 viruses

A test to detect Covid-19 viruses in saliva rather than nasal swabs received emergency authorization from Food and Drug Administration. . . . → Read More: Covid-19 Saliva Test Earns FDA Emergency Clearance

FDA Issues Guidance to Boost Clinical Trial Diversity

Medical gear

Food and Drug Administration issued new regulatory guidance designed to enroll clinical trial participants more representative of the populations they claim to serve. . . . → Read More: FDA Issues Guidance to Boost Clinical Trial Diversity