STAT+: Travere’s drug for a kidney disease doesn’t improve kidney function. The FDA approved it anyway
How a rare disease drugmaker won FDA approval after a clinical trial disappointed.
How a rare disease drugmaker won FDA approval after a clinical trial disappointed.
The anti-amyloid drug class has yielded some FDA approvals and plenty of failed candidates. Now, researchers are looking at the overall track record of the group and painting an unpleasant picture about the efficacy of these drugs.
RFK Jr. has a delicate task ahead of him as he faces a marathon of hearings on Capitol Hill.
Rather than relying on patient groups to make an impassioned plea, Roche aims to put doubts to rest around the controversial Duchenne muscular dystrophy gene therapy Elevidys with the rigor of another clinical study.
Eli Lilly is wasting no time in pursuit of the next indication for its newly christened obesity pill Foundayo, presenting new data in diabetes Thursday that also serves to address the FDA’s desire for more safety info on the oral GLP-1.
Omnicom Health has stamped its mark on the recently acquired FCB Health New York, rebranding the ad agency as Olixir New York in the aftermath of the mega-merger with Interpublic Group.
A rogue set of “zombie” immune cells may be driving aging and fatty liver disease by flooding tissues with inflammation. Researchers found these cells accumulate with age and high cholesterol—and can make up most of the liver’s immune cells in older mice. When scientists removed them, liver damage was dramatically reversed, even without diet changes.
A massive, nearly 20-year study tracking over 650,000 Americans with irritable bowel syndrome is raising new questions about the long-term safety of common treatments. Researchers found that some widely used medications—including antidepressants and certain antidiarrheal drugs—were linked to a small but noticeable increase in the risk of death over time.
New research suggests that aiming for a lower blood pressure target may deliver bigger heart health benefits than previously thought. Using large datasets and simulation models, scientists found that keeping systolic blood pressure below 120 mm Hg could reduce the risk of heart attack, stroke, and heart failure more than higher targets.
A surprising new clinical trial has revealed that metformin—a cheap, century-old drug widely used for type 2 diabetes—may help people with type 1 diabetes in an unexpected way. While researchers initially hoped it would reduce insulin resistance, they instead found it allows patients to use about 12% less insulin while maintaining stable blood sugar levels.
CMS is proposing to repeal a pathway that allows breakthrough devices to get supplementary payments.
The FDA’s Pharmacy Compounding Advisory Committee will convene this summer to discuss seven peptides that are currently restricted from use in compounded medications.
With Daiichi Sankyo’s priorities increasingly tied to its innovative medicines—and its oncology portfolio in particular—the Tokyo-based drugmaker is following in the footsteps of several of its peers with a deal to split from its consumer health business.
Revolution Medicines $2B fundraise, Structure's new hire hints at acquisition efforts, and more Readout biotech news
The FDA will convene an outside panel of advisers to discuss whether to allow compounding pharmacies to manufacture certain peptides
The company and its global distrubution partner the Global Fund expanded its commitment to bring Yeztugo to 3 million people worldwide by 2028, but Doctors Without Borders (MSF) says supply is still "not nearly enough."
Beeline Medicine is focused on development of five inflammatory and immune disorder drugs, starting with a potential daily pill for lupus.
AI heavyweight Anthropic has appointed Novartis CEO Vas Narasimhan to its board of directors as the link between the pharmaceutical industry and Silicon Valley deepens.
For Astellas’ chief manufacturing officer, Rao Mantri, Ph.D., production is not just about a reliable supply of a pharmaceutical product. Manufacturing serves as a crucial bridge that helps link promising research to patients in the real world, too.
Lucy Liu has joined Pfizer’s mission to deliver a knockout blow against cancer, becoming the latest face of the Big Pharma’s campaign encouraging people to get screened.