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Lexeo wants to more quickly move investigational gene therapy LX2006 into a registrational study and hopes for a potential efficacy readout in 2027.
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A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer them found that 2024 was the busiest year yet. Companies have disclosed spending $513 million on vouchers that were earned in 2024 so far.
Konstantina Katcheves, Senior VP of Innovative Global Business Development at Teva Pharmaceuticals brings insights from the World Economic Forum to SCOPE 2025.
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
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Topline overall survival results from the TROPION-Lung01 phase 3 trial, which previously met the dual primary endpoint of progression-free survival, numerically favored datopotamab deruxtecan compared to docetaxel in the overall trial population of adult patients with locally advanced or metastatic non-small cell lung cancer treated with at least one prior line of therapy.
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Read our takes on the biggest stories happening in the industry.
Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach.
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Despite steep budget and staffing cuts at the FDA in recent weeks and other headwinds, Gilead CEO Daniel O’Day assured investors that the pharma’s plans and preparations for lenacapavir’s launch remain on track.
Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.
Despite a dip in sales and a recent schizophrenia stumble, the company drew an optimistic outlook for sales for the rest of the year, even as the specter of pharmaceutical tariffs looms.
Merck, Bristol Myers Squibb, Sanofi and Roche had little clarity on the potential impact of President Donald Trump’s pharmaceutical tariffs but many companies are already preparing for what’s to come.
Granite will focus on two antibody therapies, both targeting crucial players in the inflammatory cascade to address autoimmune diseases.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses how collaboration and investment shape the the future of women’s health with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
With a new raise provided by Flagship Pioneering, the new company is aiming to find “the silent window” before disease symptoms set in.
The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
Proquad is rarely a newsmaker from Merck’s earnings, but this time around, the U.S. has had a series of measles outbreaks. Sales of the vaccine were $539 million for the quarter, a 5% decline from the same period in 2024.