In a clear sign that the FDA is raising the bar for accelerated approvals, the agency has declined to grant Accelerated Approval for donanemab — Eli Lilly’s entry into the antiamyloid antibody race — saying there isn’t enough long-term data to support such a move.
To View This Article:
Subscribe To Drug Industry Daily
Drug Industry Daily Subscription
Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators ... and what their competitors are up to.
Don't waste your time on unending, unproductive online searches for news stories, reports and opinion; let DID's experienced in-house editorial team do the work for you. Use your energy where it's needed most — ensuring that your products are in compliance and getting to market as quickly as possible.
You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.
PLUS: in every issue, you get links to additional documents that support DID’s articles, such
as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of
proposed legislation, and many others.
There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug Industry Daily, you may cancel your subscription and receive a full refund. No questions asked.
So, why wait? Become a subscriber to Drug Industry Daily today. It couldn’t be easier.