Medications

U.S. FDA Grants Accelerated Approval to Trodelvy for the Treatment of Metastatic Urothelial Cancer

FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 13, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 […]

Health News

FDA updates Moderna COVID-19 vaccine EUA in bid to speed rollout

Moderna to create vaccine to fight both COVID-19, flu Fox News medical contributor Dr. Janette Nesheiwat says Moderna developments are ‘incredible’ and argues the dual vaccine will very likely ‘save lives.’ The FDA announced two revisions to the emergency use authorization (EUA) granted to Moderna’s COVID-19 vaccine in the hopes that it will help expedite […]

Medications

FDA Approves Roszet

FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia Morristown, N.J. March 31, 2021 — Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult […]

Health News

FDA Grants EUA to COVID Screening Device for Asymptomatic People

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for a screening device that identifies biomarkers that may indicate asymptomatic SARS-CoV-2 infection in people ages 5 and older. The Tiger Tech COVID Plus Monitor (Tiger Tech Solutions, […]

Health News

Benefits of Drug for Women With Hyposexual Disorder Questioned

Bremelanotide, a Food and Drug Administration–approved treatment for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, may be of limited use, suggests Glen I. Spielmans, PhD, in a new analysis paper. Spielmans, professor of psychology at Metropolitan State University in Saint Paul, Minn., examined data from the FDA application for bremelanotide, clinicaltrials.gov entries […]

Health News

Alzheimer’s Association Denies Conflict in Aducanumab Support

The Alzheimer’s Association is denying accusations by two researchers in the field and a watchdog group that its repeated endorsement of aducanumab, a drug under US Food and Drug Administration (FDA) review for the treatment of Alzheimer’s disease (AD), has been unduly influenced by financial support from the two companies seeking approval, Biogen and Eisai. […]

Medications

FDA Approves Cabenuva and Vocabria

FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment London, 21 January 2021 – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first […]