The loss of special government employee status for four members of the CDC’s Advisory Committee on Immunization Practices ...

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

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 ...

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

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

Leaders from the world of cell and gene therapy shared their personal stories and policy recommendations in an extraordinary ...

For MPTs, this could be the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), or Center for Devices and Radiological Health (CDRH) within the US FDA.

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

Analysts reacted positively to the news that uniQure is in alignment with the FDA on an accelerated approval pathway and on ...

The U.S. health secretary said people should have access to experimental therapies including unregulated uses of stem cells.

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

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