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Bristol Myers Squibb has withdrawn the U.S. indication for its blockbuster drug Opdivo (nivolumab) for treatment of small cell lung cancer, following disappointing clinical trial results. Read More
A federal appeals court ruling last year against Teva Pharmaceuticals threatens other generic drugmakers, according to an amicus brief filed Dec. 22 by a roll call of professors of law, economics, business, health and medicine. Read More
The long-time director of the FDA’s Center for Drug Evaluation and Research (CDER), Janet Woodcock, who stepped aside last year to head the therapeutics arm of the U.S. government’s Operation Warp Speed (OWS) initiative, is taking up a new role as principal medical adviser to FDA Commissioner Stephen Hahn. Read More
Effective Jan. 1, drugmakers can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). Read More
HHS has made it known that pharma companies are required to offer 340B discounts for covered drugs even when they’re distributed by contract pharmacies, speaking out after several big drugmakers began withholding them. Read More
HHS has ordered the FDA to “cease further collection efforts” related to the Over-the-Counter Drug Monograph User Fee Program and has withdrawn the agency’s Dec. 29 Federal Register notice on user fee rates. Read More
The FDA made the right call in strongly advising against using a half-dose regimen of Moderna’s COVID-19 vaccine to stretch supply and vaccinate more Americans, members of the agency’s vaccine advisory panel told FDAnews. Read More
FDA has published two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More
A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Read More
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued late last month. Read More
The FDA is working on a report tied to a two-day meeting held in December to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. Read More