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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Crohn’s disease should add reduction of intestinal inflammation to their symptom-relief endpoints, according to an FDA draft guidance released Thursday in tandem with a draft guidance for conducting ulcerative colitis trials.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
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
Johnson & Johnson (J&J) subsidiary Janssen has become the second big pharma company to go after drug distributors to stop the sale of counterfeit versions of its HIV drugs. Read More
Sen. Elizabeth Warren (D-Mass.) has written to ask Health and Human Services Secretary Xavier Becerra to lower prescription drug prices using an obscure and controversial regulatory authority known as “march-in rights.” Read More