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Scientists who focus only on generating data risk missing their role in shaping strategy and driving innovation.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
THE LATEST
Johnson and Johnson kicked off first-quarter earnings season with a “modest” beat and an ambitious goal; Replimune failed again to gain approval for its advanced melanoma therapy, as analysts tout increased accountability brought by the FDA’s new policy of publicizing complete response letters; and Revolution Medicines’ pancreatic cancer candidate doubled survival in one of cancer’s most intractable foes.
Amidst rising layoffs in key biotech hubs, global demand for specialized life sciences talent is driving a more borderless, distributed model of scientific work.
Gilead, AstraZeneca and Vertex have acquired more than just a therapeutic asset in recent deals. BioSpace takes a look at five recent transactions where the staff was the real centerpiece.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The draft guidance supports the agency’s new pathway designed to speed up the development of custom gene therapies.
By closing the Universal Cells Seattle location, Astellas is reportedly consolidating cell therapy, gene therapy and oncology research at its South San Francisco, California, and Westborough, Massachusetts, sites.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q1 job market performance and what it signals for the coming months.
With robust sales performance from oncology darling Darzalex and immunology superstar Tremfya, Johnson & Johnson is “off to a fast start in 2026,” CEO Joaquin Duato told investors on Tuesday.
With many overseas patients preferring orals to injectables, Eli Lilly has filed for approval of orforglipron in more than 40 countries and is building manufacturing capacity to support the obesity drug.
Eli Lilly is putting its obesity windfall to work again, striking a new deal to acquire CrossBridge Bio, a small Texas biotech known for its cancer tech.