Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...

This is what it looks like when disinformation doctors pretend to value data and science to further their true objective, ...

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER ...

The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the ...

Biotech stumbled in FY25, but we didn’t. HB Biotechnology kept its footing and delivered 23% outperformance in a tough market ...

The nascent leadership team assembled by Kennedy consists of highly talented and respected experts in their fields. Let’s ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

Congress is expected to vote next week on President Donald Trump’s request to claw back $9.4 billion in congressionally ...

The FDA has loosened safety restrictions for six CAR T-cell immunotherapies, used in treating a number of blood cancers.