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FDA Acting Commissioner Janet Woodcock has denied that the FDA’s moves to delay several drug reviews are a sign that the agency is becoming less flexible in its evaluations, advising people not to read too much into the recent delays. Read More
New data from Moderna’s phase 3 COVID-19 vaccine trial have shown that the U.S. drugmaker’s two-dose inoculation remains highly effective against the virus six months after the second shot, including for severe infection, the company said Tuesday. Read More
Watchdog group Public Citizen has asked FDA to add recently banned weight loss drugs and antibiotics to the official list of drug products that were withdrawn or removed from the market for reasons of safety or effectiveness. Read More
A federal agency has drafted recommendations calling on Congress to require drugmakers to pay higher Medicaid rebates for high-cost specialty drugs until they complete confirmatory trials following accelerated approvals by the FDA. Read More
As Democratic lawmakers push ahead for legislation this congressional session aimed at lowering U.S. drug prices, PhRMA has come out with a seven-figure national ad campaign and a new policy agenda that puts forward ideas of its own for lowering the costs of drugs. Read More
An expert panel of the Centers for Disease Control and Prevention (CDC) is meeting today to review blood-clot incidents reported in a handful of patients who received Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine. Read More