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Trials of drugs to treat Crohn’s disease should add reduction of intestinal inflammation to their symptom-relief endpoints, according to an FDA draft guidance released Thursday in tandem with a draft guidance for conducting ulcerative colitis trials. Read More
Amgen disclosed this week that the Internal Revenue Service (IRS) is seeking $7.1 billion in back taxes and fines relating to how the drugmaker split profits between its U.S. and Puerto Rican manufacturing hubs. Read More
IQVIA has come out with a new report that looks back at the historic timelines achieved by the COVID-19 vaccine trials, outlining lessons learned from the unprecedented research effort that have application now and in future research. Read More
Moderna announced yesterday that it has filed for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in children less than six years old as the FDA comes under intense pressure from many sides to swiftly authorize the vaccine for this population. Read More
The FDA needs funding for technological advancements and updated infrastructure, buildings and facilities, Commissioner Robert Califf told a Senate subcommittee discussing the agency’s fiscal year 2023 budget requests. Read More
The potential blockbuster drug has also received the FDA’s accelerated approval for the treatment of unresectable or metastatic HER2-positive breast cancer. Read More
The FDA is seeing “new lows in data integrity” relating to generic drug applications, an agency official said at the agency’s two-day Generic Drugs Forum 2022, April 26-27. Read More
The FDA has issued warning letters to five drugmakers producing several products including topical anesthetics, skin-bleaching products and hand sanitizers. Read More
The FDA has issued final guidance for industry on making postmarket safety submissions in electronic format to its Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER). Read More