Drugs

FDA Gives Expedited Review for Lilly Obesity Pill

Senior FDA officials have urged agency reviewers to speed up the review of Eli Lilly’s NDA for its oral weight loss pill orforglipron after the drugmaker pushed for a faster review timeline, according to a report from Reuters. It says the shorter review would fall under the Commissioner’s National Priority Review voucher program.

If everything works out and the company responds promptly to any reviewer request, Reuters says an FDA decision on orforglipron’s filing could be expected by as early as 3/28/2026, well ahead of the original user fee review target date of 5/20/2026.

Novo Nordisk also has an oral version of its weight-loss therapy Wegovy currently under FDA review, with a decision expected this month.

News of Lilly’s expedited review comes on the heels of promising data just released on its investigational triple-agonist retatrutide, which produced substantial weight loss and meaningful reductions in knee osteoarthritis pain in a pivotal Phase 3 trial (see story).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome