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.
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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.
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The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.
The FDA placed a clinical hold on Magenta’s clinical program for acute myeloid leukemia and myelodysplastic syndrome, which made its shares drop nearly 7% this morning.
Genentech announced that the FDA has green-lit the Venclexta classification and azicitidine combination as a Breakthrough Therapy Drug.
Pfizer has voluntarily recalled two lots of Chantix 0.5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit consisting of 0.5mg/1 mg tablets.
The FDA said it found an issue with the “size of the treatment effect and clinical relevance” of Ardelyx’s new drug tenapanor without providing additional details.
On Friday, the agency approved belumosudil as a new treatment option for anyone over 12 with cGVHD after two prior lines of therapy have failed.
The CDC Advisory Committee on Immunization Practices is planning a meeting in October to recommend the vaccine’s use in adults.
The FDA has historically tended to keep more contentious relationships with some companies private. But recently, the agency appears to be publicly scolding some biopharma companies.
It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.
The company said that it values the FDA’s feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.