FDA
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
FEATURED STORIES
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Eisai said that they have initiated communication with the FDA to achieve “the most optimal regulatory pathway” for lecanemab.
Sage announced the termination of the REDWOOD and RAINFOREST studies of zuranolone, which is being assessed to treat both major depressive disorder and post-partum depression.
The FDA’s Treosulfan rejection was surprising for both Meduxus and Medac. The FDA has provided a Complete Response Letter and made some recommendations.
The company announced that it is withdrawing its peripheral T-cell lymphoma drug Istodax from the market after recent trials showed that it does not achieve its primary efficacy endpoint.
The drug, created by Vaxart, has just completed its Phase I trial and had submitted an Investigational New Drug application to move forward.
Seventeen years after buying global rights, AstraZeneca is finally announcing a win for the lupus community with an FDA approval for Saphnelo.
The U.S. FDA is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.
The FDA has already given its go-ahead to use lumasiran to treat PH1 and lower the urinary oxalate levels in pediatric and adult patients under the brand name OXLUMO.
Shares of Ardelyx, Inc. have fallen nearly 13% in premarket trading after the U.S. FDA rejected the company’s chronic kidney disease drug, tenapanor.
As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.