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…
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…
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. Source: Drug…
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…
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. Source:…
The FDA has issued warning letters to five drugmakers producing several products including topical anesthetics, skin-bleaching products and hand sanitizers. Source: Drug Industry Daily
After pocketing positive phase 3 topline results, Novartis will ask regulators to approve its checkpoint inhibitor tislelizumab as first-line add-on therapy for patients with previously untreatable esophageal squamous-cell carcinoma (ESCC).…
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. Source: Drug…
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…
In a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP) yesterday, ranking member Sen. Richard Burr (R-N.C.) characterized the funding in the FDA’s reauthorization agreements as…