Despite the FDA commissioner’s promises of partnership and collaboration, personnel changes and continued federal cuts create ...

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

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

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

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

Capricor Therapeutics's dip caused by the CRL is a buying opportunity considering the readout of HOPE-3 within 2-3 months.

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

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

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

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

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 ...

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...