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Medpage Today on MSN22h
FDA Officials Lay Out Vision for Agency
The new FDA commissioner and Center for Biologics Evaluation and Research (CBER) director laid out their vision for the ...
pharmaphorum4h
Makary, Prasad set out their vision for the FDA
Makary and Prasad also repeat various themes repeatedly visited by Kennedy on his Make America Healthy Again (MAHA) soapbox, ...
BioSpace55m
As Gene Therapy Endures ‘Cold Winter,’ FDA Leaders Promise Support
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the ...
BioSpace6d
FDA’s Prasad Vows To Make Rare Disease Drugs Available at ‘First Sign of Promise’
The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines ...
US Health Secretary Kennedy looks to fast-tracking approvals for rare disease drugs
Health and Human Services Secretary Robert F. Kennedy Jr. said on Thursday that the U.S. drugs regulator would look for ways ...
Mirage News5d
Chikungunya Vaccine Pause and Fast-Track Approval
This Viewpoint, by Vinay Prasad, MD, MPH, of the Center for Biologics Evaluation and Research, Food and Drug Administration, and ...
GEN - Genetic Engineering and Biotechnology News5d
Cell and Gene Therapy Leaders Tell FDA: “Believe in American Solutions”
Leaders from the world of cell and gene therapy shared their personal stories and policy recommendations in an extraordinary ...
STAT5d
Pharmalittle: We’re reading about GLP-1 drugs and eye disease, European pharma reforms, and more
HHS Secretary Robert F. Kennedy Jr. said that the FDA would look for ways to fast-track approval for rare disease treatments ...
STAT2d
Pharmalittle: We’re reading about FDA and gene therapies, a kidney disease showdown, and more
Fears about the FDA imposing steep barriers to gene therapies for rare diseases appeared moot at an agency roundtable ...
Just The News22h
'Rubber stamp' vaccine advisory board fired by RFK Jr. for conflicts of interest has revealing past
CDC's Advisory Committee on Immunization Practices once recommended vaccine after official admitted it had no data on ...
BioSpace5d
RFK Jr. Joins Deputies in Voicing Support for Regulatory Flexibility for Cell and Gene Therapies
In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that ...
Opinion
Science-Based Medicine1dOpinion
Marty Makary and Vinay Prasad embrace a “more fluid concept of evidence” at the FDA
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 ...