Drug Development
The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have had a hand in; Compass Pathways posts new late-stage data on its psilocybin-based depression drug; CDC is once again leaderless.
FEATURED STORIES
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
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The FDA recommends a randomized trial to adequately assess drug efficacy and safety of P13K inhibitor drug candidates.
The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.
Small Pharma Inc. is developing a new approach to treat major depressive disorder (MDD) without using SSRIs or standard medications. Here’s what they are using.
In honor of March 24, World TB Day, BioSpace looks at clinical trials and eradication efforts occurring today.
The Phase II trial is evaluating zepzelca as a monotherapy in patients with urothelial carcinoma, large cell neuroendocrine carcinoma of the lung and HRD tumors.
AstraZeneca shared that using imfinzi alongside chemoradiotherapy did not meet statistical significance in improving progression-free survival versus using CRT alone.
A recent study in mice was able to halt memory decay in a model of Alzheimer’s disease. Another study found that even mild infection increased the risk of new-onset type 2 diabetes, although the risk increased with the severity of COVID-19.
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
The FDA approved Pluvicto (targeted radioligand therapy) for use in adults with PSMA-positive mCRPC that has already metastasized to other body parts.
BioAge Labs presented new data demonstrating how its drug candidate BGE-175 is uniquely poised to tackle age-related immune system decline that leads to disease progression.