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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Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.
The new authorization is expected to be the final reassurance for many of those who had hesitated when the vaccine was approved under emergency use only.
The FDA has approved the use of the injectable drug KORSUVA in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
Many expect the full approval will lead to vaccine mandates, as that was one of the obstacles to it for many organizations.
The U.S. FDA has a busy schedule for the end of August and beginning of September. Let’s take a look.
Makena injection currently remains on the market but is poised to be removed pending the outcome of the meeting. The final decision will be made in the public hearing.
Specifically, the new approval was for adults with dMMR recurrent or advanced solid tumors who have progressed on or after previous treatment and who have no satisfactory alternatives.
The FDA recommended additional clinical and statistical data analyses of Vicineum, as well as issues related to the company’s Chemistry, Manufacturing, and Controls.
This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.