Policy
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
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An unnamed source clarified that Sandra Retzky has not been fired from the FDA, but it remains unclear where she was reassigned.
The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.
A new version of the controversial bill removes the specific company names that were included in a previous iteration but still requires the industry to ditch Chinese biotech contractors in order to receive federal dollars.
The British proposal to increase support for pharma is “clearly positive,” according to analysts at Leerink, who noted that the NHS’ move will improve patient access to treatments.
The CDC’s Advisory Committee on Immunization Practices was scheduled to convene Oct. 22 to 23, but this meeting has been postponed, with no new date specified. The delay comes as the VA published new research showing that COVID-19 shots prevented hospitalizations and death.
The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.
A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals.
Jeanne Marrazzo, former director of the National Institutes of Allergy and Infectious Disease, was formally terminated Thursday after months on administrative leave, after filing a whistleblower report.
Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014.