Drug Development
Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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’s decision to lift the hold directive on April 11 involving the investigational drug magrolimab follows a comprehensive review of each trial’s safety data.
As Aeglea presents the data this week at the Society for Inherited Metabolic Disorders (SIMD), its stock has responded to both announcements with a strong leap.
EXUMA Biotech is developing a new modality to produce CAR cells in a single day, with potentially lower toxicity and higher efficacy without the need for preparative chemotherapies.
Cytovia could become the first company to use a combination of natural killer (NK) cells derived from induced pluripotent stem cell (iPSC) and NK engager antibodies to treat solid tumors.
Veru posted positive interim Phase III data from its late-stage study assessing oral antiviral sabizabulin in hospitalized COVID-19 patients. Here’s more about it.
Curis, a biotech company that develops treatments for cancer, has announced that the FDA has placed a partial clinical hold on its TakeAim lymphoma study.
The American Association for Cancer Research (AACR) Annual Meeting is running from April 7-13 in New Orleans. Here’s a look at some of the preclinical and early-stage studies recently presented.
Some researchers are pointing to the need for an intranasal approach to vaccination in order to block the viral particles from gaining a foothold in the body at the point of entry – the nose.
Following the decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm, the Alzheimer’s community is now waiting for other companies to deliver new therapies.
The FDA is looking at revising the current vaccine strategy and emphasizing that individuals need to consider their own risk tolerance. For that and more, continue reading.