The FDA approves leucovorin for a rare brain disorder while retreating from top officials’ earlier insistence that it could benefit many children with autism.

Novo Nordisk received a warning from the Food and Drug Administration for failing to report suspected incidents of side effects caused by its medicines, a step that is required by federal law. In a ...

Sen. Ron Johnson said he spoke to FDA Commissioner Marty Makary about the agency’s handling of rare disease treatments.

AI scribe company Nabla aims to be much more by using tech from Yann LeCun's new startup AMI, which just raised $1 billion.

The exit of the FDA’s Vinay Prasad is being chalked up to a series of controversial decisions on rare disease drugs by the biologics center he directed. Read Lizzy Lawrence’s article on his upcoming ...

In the breakup between Dana-Farber Cancer Institute and Mass General Brigham, the sides have decided to go with conscious uncoupling rather than an acrimonious divorce.

The co-founders of the Covid-19 vaccine developer BioNTech plan to leave the biotech to start a new mRNA-focused company ...

Ugur Sahin and Özlem Türeci, the couple who co-founded BioNTech, are leaving the Covid-19 vaccine maker to start a new, mRNA-focused firm.

Removing race from the eGFR had a big impact, resulting in 5.3 more kidney transplants per 1000 Black candidates.

Novo Nordisk and Hims & Hers have reached a deal that, for now, appears to end their bitter dispute around Hims’ sale of compounded versions of Novo’s blockbuster obesity drug Wegovy.

As the Super Bowl approached halftime, Hims & Hers publicly staked its claim to preventive medicine in front of the American people. In a one-minute ad, the direct-to-consumer health company ...

For physician Vishal Khetpal, the legal battle between Hims & Hers and Novo Nordisk (which, by the way, was settled yesterday) is just one symptom of something much larger going on with American ...