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 biopharma industry has started 2022 with plenty of clinical trial news. Here’s a look.
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
The FDA decided to lift the hold for its Phase IIa trial of SPR720 after Spero submitted a comprehensive analysis from the NHP toxicology study.
Today, the FDA approved two new drug applications. One is for Spero’s tebipenem HBr oral tablets and the second is CStone’s IND application for CS5001.
Applied Therapeutics said it is holding off on a New Drug Application after discussions with the FDA, which appears to require additional clinical data.
Just as 2021 was wrapping up, the U.S. FDA had some end-of-year activity. Here’s a look.
Novavax vaccine’s emergency use authorization application has been submitted to FDA recently. Novavax is hoping to bring it to the Finish Line in 2022.
The decision to allow the release of Adbry follows positive results from the Phase III ECZTRA trials, which covered almost 2,000 patients living with moderate to severe atopic dermatitis.
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.