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Baxfendy, the first aldosterone synthase inhibitor to be approved by the FDA for high blood pressure, is among the products AstraZeneca is relying on to hit its 2030 goal of $80 billion in revenue.
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The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The biotech company has bought the global rights to an investigational oral CDK2 inhibitor from Ensem Therapeutics in a licensing agreement valued at up to $1.33 billion if all milestones are met.
The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.
Vorasidenib decreased tumor volume by a mean of 2.5% every six months, compared to growth of 13.9% for placebo over the same time span. The candidate is also being tested in a regimen with Keytruda.
As companies clamor for a piece of the antibody-drug conjugate pie, experts pose the question: is it possible to replicate the success of Enhertu?
Bayer’s investigational factor XIa inhibitor asundexian was inferior to BMS’ and Pfizer’s blockbuster blood thinner Eliquis (apixaban) in the Phase III OCEANIC-AF study.
Armed with a pipeline of obesity and diabetes hopefuls, Carmot Therapeutics joins the small group of biotechs to attempt a Nasdaq debut this year.
The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.
In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.
The company’s Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.
Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.