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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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Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here’s a closer look.
As MSLs take on greater roles in healthcare, standardization is crucial to fostering trust.
While Astellas did not say why it withdrew its suit, it was the only company to file a legal complaint that wasn’t on the initial IRA drug price negotiations list and may not have had any grounds to sue.
Soon after cancelling its contract with I-Mab, AbbVie has now also turned its back on a partnership with Berkeley-based Caribou Biosciences that was focused on advancing allogeneic CAR-T therapeutics.
Following promising results in major depressive disorder, Alto Neuroscience on Tuesday reported positive data for its investigational drug ALTO-100 in post-traumatic stress disorder.
Despite filing respective lawsuits challenging the program, AstraZeneca and Bristol Myers Squibb have decided to participate in the first round of price negotiations under the Inflation Reduction Act.
The Italian pharma company is acquiring what was once one of the hottest stocks in the biotech sector, just months after the FDA rejected Intercept’s non-alcoholic steatohepatitis candidate.
Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.
The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.
The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.