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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 company unveiled plans last week to test its GLP-1/glucagon dual receptor agonist in alcohol use disorder and alcohol-related liver disease.
Dyne is eyeing an accelerated approval filing for DYNE-251 in early 2026 that would pit the asset against Sarepta’s Exondys 51 in a patient population amenable to exon 51 skipping.
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.
Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year.
Ionis and Ultragenyx are competing to develop oligonucleotide treatments for Angelman syndrome, but will Neuren’s peptide catch up?
The Maryland-based biopharma joins Eli Lilly and Novo Nordisk in trialing a GLP-1 agonist for alcohol- and liver-related conditions.
Pfizer was studying PF-07820435, an orally available agonist of the STING protein, for solid tumors.
Sutro’s stock tumbled nearly 19% after the company announced it will sideline its FRα-targeted antibody-drug conjugate luveltamab tazevibulin, which it was studying for ovarian cancer. The biotech will seek licensing opportunities for the asset.
Pliant follows in the footsteps of Acelyrin, which also enacted a stockholder rights program on Thursday to protect shareholders against Tang Capital’s growing stake in the company.
The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.