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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BioSpace looks back at 2025 and where the FDA is going in 2026.
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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Despite an uncertain legislative path to becoming law, the BIOSECURE Act has already impacted the biopharma industry’s confidence in Chinese service providers and prompted efforts to diversify manufacturing partners.
As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit.
This week on Denatured, Head of Insights Lori Ellis and guests discuss the implications of not addressing the DE&I data gaps for the future.
The Department of Justice and Securities and Exchange Commission are investigating two senior employees of Cassava Sciences in connection with allegations of data manipulation for its Alzheimer’s disease candidate simufilam.
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after the company allegedly ignored directives to withdraw or amend contentious patent listings on the FDA’s Orange Book.
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
Daiichi Sankyo has secured a victory in its patent arbitration with Seagen, nabbing a $47 million award for attorneys’ fees and other costs, plus interest. However, a larger patent battle with Pfizer remains.
In a potential challenge to Pfizer’s Prevnar 20, Merck’s Capvaxive has been recommended by the Centers for Disease Control and Protection for use in preventing invasive pneumococcal disease in adults.
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
Rocket Pharmaceuticals’ gene therapy Kresladi has been hit with an FDA Complete Response Letter requesting additional chemistry, manufacturing and controls information to complete its review.