Shares of Cassava Sciences were up more than 5% in premarket trading on February 11 after the U.S. Food and Drug Administration denied a Citizen Petition filed during 2021 on behalf of short-selling clients who sought to suspend the company’s Alzheimer’s clinical trials.
As the United States makes efforts to eradicate Covid-19 under a new president’s administration, the Food and Drug Administration is tasked with rebuilding the regulatory agency’s reputation with a new commissioner.
Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration, is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
A panel of outside advisers to the U.S. Food and Drug Administration voted that a potential Alzheimer’s treatment from Biogen Inc. has not been proven to slow progression of the disease, a sharp rebuke to agency staff who had praised the drug.
In an aim to create a strong domestic supply chain, President Donald Trump signed an Executive Order that calls for federal agencies to purchase “essential drugs” and medical supplies that are produced in the United States, rather than from abroad as is the current practice.
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s Ofev (nintedanib) for patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype.
The U.S. Food and Drug Administration announced a new pilot program aimed at stimulating the use of complex innovative clinical trial designs for drugs and biologics.