A senior official at the CDER, which regulates prescription and over-the-counter medicines, said in a letter to Amgen on Monday that the agency can no longer conclude that “there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS |Image used for representational purpose only | Photo Credit: Dado Ruvic The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has proposed withdrawing approval of Amgen’s drug for rare autoimmune diseases, citing a lack of proven effectiveness and false statements in its original application. Published – April 28, 2026 01:03 pm IST Share this: Click to share on WhatsApp (Opens in new window) WhatsApp Click to share on Facebook (Opens in new window) Facebook Click to share on Threads (Opens in new window) Threads Click to share on X (Opens in new window) X Click to share on Telegram (Opens in new window) Telegram Click to share on LinkedIn (Opens in new window) LinkedIn Click to share on Pinterest (Opens in new window) Pinterest Click to email a link to a friend (Opens in new window) Email More Click to print (Opens in new window) Print Click to share on Reddit (Opens in new window) Reddit Click to share on Tumblr (Opens in new window) Tumblr Click to share on Pocket (Opens in new window) Pocket Click to share on Mastodon (Opens in new window) Mastodon Click to share on Nextdoor (Opens in new window) Nextdoor Click to share on Bluesky (Opens in new window) Bluesky Like this:Like Loading... Post navigation House of TI, Tilaknagar Industries’ Luxury Portfolio, Wins Four Awards at the London Spirits Competition Odisha mining project protest: Congress seeks independent probe; alleges PESA, FRA violations