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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Pfizer announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
Belgium-based Celyad Oncology voluntarily paused a clinical trial with Merck after two deaths. Getting CAR T therapies to work in solid tumors has proven to be a difficult challenge.
The FDA rejected Gilead’s New Drug Application, citing Chemistry Manufacturing and Controls (CMC) problems associated with the compatibility of the drug with the proposed container vial.
In 2021, Sanofi earned about $4.2 billion from Dupixent sales, and Regeneron earned about $1.8 billion.
Johnson & Johnson’s partner, Legend Biotech, has been awarded FDA approval for its (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma disease.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.