FDA Under Pressure to Grant Full Approval to Covid-19 Vaccines

The U.S. Food and Drug Administration is under pressure to swiftly grant full approval to Covid-19 shots, as vaccine mandates take on new urgency for schools, hospitals and employers amid surging cases from the rapidly spreading Delta variant. Government agencies and companies

FDA Wants Larger Number of Children in Vaccine Tests

The Food and Drug Administration has raised the minimum number of young children that should be in Covid-19 vaccine trials to better detect any side effects, people familiar with the matter said. A big reason for the change, one of the people

FDA Narrows Suggested Uses for New Alzheimer's Drug

U.S. health regulators narrowed the prescribing instructions for the first new Alzheimer’s drug in nearly two decades, recommending the therapy be given to people with early-stage symptoms of the disease. The change recommends use of the drug, Aduhelm from Biogen Inc., be

FDA Approved Alzheimer's Drug Despite Some Staff Concerns

The U.S. Food and Drug Administration approved the first new Alzheimer’s drug in decades over the objection of agency statisticians who said there was insufficient evidence to support approval, according to newly released internal memos. In the internal memos released Tuesday, FDA

First Alzheimer's Drug to Slow Disease Is Approved by FDA

U.S. health regulators approved the first new Alzheimer’s drug in nearly two decades, casting aside doubts about the therapy’s effectiveness. The approval Monday of the therapy, which has the molecular name aducanumab and will be sold as Aduhelm, marked a watershed in

Regeneron's Covid-19 Drug Is Authorized for Injection

U.S. health regulators have authorized newer, more convenient forms of a Covid-19 antibody drug made by Regeneron Pharmaceuticals Inc. REGN 0.06% that could make it easier for patients to get the treatment, the company said on Friday. Doctors and nurses now can