News
FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
FEATURED STORIES
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
As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure.
To more effectively treat neurodegenerative conditions, we first need diagnostic tools that lend a more complete picture of protein aggregates in the brain.
At the intersection of radiation and precision, Novartis, Bayer, AstraZeneca and more hope to cash in on a radiopharmaceuticals market that could top $16 billion by 2033.
In a recent BioSpace LinkedIn poll, nearly half of respondents predicted the job market won’t turn around until 2027 or later. It’s easy to see why people are skeptical, especially when you consider recent hiring activity and layoffs.
With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.
Insitro’s layoffs affect about 65 employees as the AI-focused biotech looks to advance its pipeline in metabolic disease and neuroscience.
After losing its powerhouse partner, IGM Biosciences closed “most” of its labs and offices and initiated a strategic review of potential strategic alternatives and options for the business.
The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the rollout immediately.
The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action dates.
The company discontinued development last month of its most mature asset, RLYB212, following disappointing mid-stage pharmacokinetic findings in a rare bleeding disorder.