Policy
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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Amgen’s Repatha may cause cardiac harm, according to a reassessment of the biologic’s late-stage trial data.
Aurinia and Sun Pharma agree to file a joint motion to dismiss a key patent dispute.
Two documents recently came to light: first, the results of a congressional investigation into the approval of Aduhelm; second, a revised clinical trial consent form for lecanemab.
The U.S. Department of Justice indicted former CytoDyn Inc. CEO Nader Z. Pourhassan and the CEO of Amarex Clinical Research on multiple counts of fraud.
Verona Pharma’s COPD candidate hits the mark in late-stage testing.
The FDA placed a clinical hold on Entrada’s experimental DMD candidate.
The FDA lifted its partial clinical hold on bluebird’s experimental sickle cell disease gene therapy for patients younger than 18.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee stood against Cytokinetics, Inc., finding that the benefits of its heart failure hopeful didn’t outweigh its risks.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.