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The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...
Makary and Prasad also repeat various themes repeatedly visited by Kennedy on his Make America Healthy Again (MAHA) soapbox, ...
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the ...
The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...
Health and Human Services Secretary Robert F. Kennedy Jr. said on Thursday that the U.S. drugs regulator would look for ways ...
This Viewpoint, by Vinay Prasad, MD, MPH, of the Center for Biologics Evaluation and Research, Food and Drug Administration, and ...
Leaders from the world of cell and gene therapy shared their personal stories and policy recommendations in an extraordinary ...
HHS Secretary Robert F. Kennedy Jr. said that the FDA would look for ways to fast-track approval for rare disease treatments ...
Fears about the FDA imposing steep barriers to gene therapies for rare diseases appeared moot at an agency roundtable ...
CDC's Advisory Committee on Immunization Practices once recommended vaccine after official admitted it had no data on ...
In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that ...
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 ...