Regulatory

Ipsen and Genfit Receive Accelerated FDA Nod for Liver Disorder Drug

Initially thought of as a potential game-changer for metabolic-associated steatohepatitis (MASH), Ipsen and Genfit’s drug elafibranor has now been successfully repurposed for treating a...

FDA expert panel backs Eli Lilly’s Alzheimer’s drug donanemab

A panel of experts advising the Food and Drug Administration announced earlier this week, with a unanimous vote, that the benefits of Eli Lilly’s...

FDA Considers Monthly Dosing for Alzheimer’s Drug Leqembi

The FDA has accepted Eisai's application for a monthly intravenous maintenance dosing option, as per the announcement. The agency is expected to make a...

FDA Advisory Committee Raises Concerns About Eli Lilly’s Alzheimer’s Drug Donanemab

The FDA’s advisory committee has raised concerns about Eli Lilly’s Alzheimer’s drug donanemab, particularly regarding the risk of brain bleeds in trial patients taking...

H7 Bird Flu Discovered on Fourth Poultry Farm in Australia

The government of Victoria in Australia announced that a highly virulent variant of avian influenza had been found on a fourth chicken farm near...

FDA Panel Will Examine Which COVID Strain Should Be the Focus of a New Vaccine

According to the FDA, the current dominant strain of COVID-19 should be a key focus during the next meeting of an FDA advisory committee,...

Amgen’s Biosimilar of AstraZeneca’s Rare Blood Condition Therapy Gets Approved by the US FDA

The U.S. Food and Drug Administration has approved Bkemv by Amgen, the first biosimilar to AstraZeneca’s Soliris, used to treat a rare blood condition....

Risk of Low Blood Sugar Identified in Novo Nordisk’s Once-Weekly Insulin Before FDA Review

Novo Nordisk aims to be the first to launch a weekly insulin product, particularly beneficial for diabetic patients with Type 1 and Type 2...

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Life Sciences Voice Top Five Newsletter

Welcome to the latest edition of the Life Sciences Voice Top Five Newsletter, your source for the top developments...

Pfizer’s Phase 3 Trial for Gene Therapy in Boys with Duchenne Muscular Dystrophy Fails to Show Functional Improvement

Pfizer's gene therapy for Duchenne muscular dystrophy failed to improve motor function in young boys in a key late-stage...

Phase 3 Trial Results for Loqtorzi Show Positive Results in Advanced Hepatocellular Carcinoma Patients

Phase 3 trial results for Loqtorzi (toripalimab) and Avastin (bevacizumab) show that in first-line patients suffering from advanced hepatocellular...

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Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

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Life Sciences Voice Top Five Newsletter

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Gilead Abruptly Halts Phase 3 Leukemia Trial Following Disappointing Data

Another failure has befallen the immuno-oncology wager...