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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Yet another busy week for clinical trial news. Here’s a look.
Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
Emergent BioSolutions, the manufacturer responsible for the doses in question, is reportedly just waiting for the U.S. FDA’s signal to start shipping the vaccines.
The letter was related to a 2021 FDA inspection connected to Sesen’s Biologics License Application for Vicineum. Read more about this sesen bio news here.
A large number of people were waiting for the breast cancer vaccine. Now, at present, the world has witnessed the first potential vaccine. Let’s take a look at it.
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
Xipere was approved for suprachoroidal use for the macular edema treatment. Macular edema is associated with uveitis, it is a form of eye inflammation.
The U.S. FDA has a busy period at the end of October heading into the first week of November.
Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.