Policy
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
FEATURED STORIES
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.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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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.