Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.

The United States Food and Drug Administration says the shortage of Eli Lilly’s Zepbound and Mounjaro drugs has been resolved and that specialty pharmacies and online companies need to stop selling off-brand versions of the weight-loss drugs. The FDA has issued warnings against the off-brand versions, citing safety concerns.

The FDA has approved Lilly's Zepbound, a glp-1 agonist, for the treatment of sleep apnea, which affects 25 million Americans and is often treated with a CPAP machine, but is often declined due to its cumbersome nature.

Eli Lilly seeks to defend its interests in a lawsuit challenging the FDA's decision on the supply status of its drugs Zepbound and Mounjaro. The lawsuit, filed by compounding pharmacies, aims to reverse the FDA's determination that these drugs are no longer in short supply.

Eli Lilly is joining in a lawsuit filed by the Outsourcing Facilities against the FDA, aiming to reverse the FDA's October 2024 determination that the shortage has been resolved, which would allow compounding pharmacies to continue selling unapproved versions of the drugs, according to court documents obtained by Becker's .

The Food and Drug Administration approved Eli Lilly’s weight-loss drug Zepbound on Dec. 27 to treat sleep apnea, a common but potentially serious sleep-related breathing disorder, making it the first medication for certain patients with the condition.

In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies to produce Victoza, also known as liraglutide, following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster.

Shares of ResMed and Inspire Medical Systems fell after the FDA approved Eli Lilly's weight-loss drug Zepbound to treat moderate-to-severe obstructive sleep apnea in adults with obesity.

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.

Following rapid (and pricey) expansion efforts from Novo and Lilly, plus recent shortage updates at the FDA, “positive signals” are emerging when it comes to the consistent supply of GLP-1 medicines for diabetes and weight loss, Bill Coyle, global head of biopharma at ZS, said in a recent interview.

Eli Lilly has asked to join in opposing a lawsuit brought by compounding pharmacies against the U.S. Food and Drug Administration over the agency's decision that Lilly's blockbuster weight-loss and diabetes drugs are no longer in short supply.