Last Thursday during a roundtable on stem cell therapies, new FDA Commissioner Marty Makary referred to EBM levels of evidence as an artificial and dogmatic construct. Apparently Dr. David Katz's "mor ...

Two weeks of upheaval at the CDC culminated Monday in the complete reconstitution of the CDC’s Advisory Committee on ...

Fears about the FDA mposing steep barriers to gene therapies for rare diseases appeared moot at an agency roundtable ...

The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...

After 307 days at CHOP, KJ was dressed in what early studies suggest are the world’s smallest and cutest graduation ...

Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a ...

Health and Human Services Secretary Robert F. Kennedy Jr. said on Thursday that the U.S. drugs regulator would look for ways ...

In the past two weeks, U.S. public health authorities have skirted normal procedures and announced two major policy changes ...

HHS Secretary Robert F. Kennedy Jr. said that the FDA would look for ways to fast-track approval for rare disease treatments ...

U.S. public health authorities have skirted normal procedures and announced two major policy changes that will likely reduce ...

In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that ...

The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug ...