Elecsys – COVID-19 antibody test receives FDA Emergency Use Authorization
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new
Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new
FDA approves new antiplatelet drug used during heart procedure – The U.S. Food and Drug Administration approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart.
ReWalk: First and Only Exoskeleton Cleared by FDA — FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries to walk – Exoskeleton leader ReWalk Robotics announced that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
FDA Orders Genetic Testing Firm 23andme to Stop Marketing DNA Analysis Service — Blocks Sale of a Company’s Mail-Order Gene Tests – The Food and Drug Administration, USA has ordered 23andme – the maker of a popular genetic-testing kit to stop sales of its heavily marketed product, saying the mail-order tests haven’t been proven effective and could dangerously mislead people about their health.
FDA takes two important actions on drug shortages — Strategic plan and proposed rule on early notification by manufacturers will help agency build on recent progress – US FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients.
FDA takes action against thousands of illegal Internet pharmacies — Agency participates in international Operation Pangea V to protect consumers from potentially dangerous, unapproved drugs – The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.
FDA approves Zaltrap for metastatic colorectal cancer – The U.S. Food and Drug Administration approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.
Breast Cancer Patients and Families Decry FDA Panel Vote to Remove Life Saving Drug From Approved List – The Oncologic Drugs Advisory Committee, FDA, USA disapproved the Avastin which cited a lack of survival benefit. Now as two more trials have been analyzed — neither showing a survival benefit — the FDA stated that in the balance, the benefit did not outweigh the harm.
FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety – The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone).