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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A day after the FDA authorized a COVID-19 booster dose of the Pfizer-BioNTech vaccine, a U.S. Centers for Disease Control and Prevention advisory committee voted in support.
The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.
FDA authorizes Pfizer-BioNTech COVID-19 booster shots for individuals 65 and over, those at high risk for severe disease and front-line healthcare workers.
FDA approved Incyte’s Opzelura (ruxolitinib) cream for atopic dermatitis (AD) for the short-term and non-continuous chronic treatment of mild to moderate AD.
It earned the FDA’s green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response.
The FDA did not identify any deficiencies related to the manufacturing of the asset. However, the agency did identify deficiencies at the facility of a CMO Verrica is working with.
Three weeks after snagging approval in the UK, the U.S. FDA approved Samsung Bioepis and Biogen’s biosimilar drug. Byooviz is the first Lucentis copycat biologic to hit the market.
FDA external advisors will meet to consider Pfizer and BioNTech data in support of booster shots. The two companies also expect to file for Vaccine Authorization for children in the coming months.
The FDA awarded a number of designations for Takeda’s candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here’s a look.