Regulatory News After a year-long reign over tumult at FDA, Makary heads for the exitFruit-flavored e-cigs were the final blow for the commissioner May 15, 2026Vol.52 No.19By Claire Marie Porter
Regulatory News Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC May 08, 2026Vol.52 No.18By Jacquelyn Cobb
Regulatory News FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients“Patients are owed another review.” May 01, 2026Vol.52 No.17By Sara Willa Ernst
Health EquityRegulatory News Self-collection kits for HPV are among innovations adding momentum to eradication of cervical cancerA kit for at-home unsupervised self-collection clears FDA finish line April 17, 2026Vol.52 No.15By Claire Marie Porter
Regulatory News Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again) March 13, 2026Vol.52 No.10By Claire Marie Porter
Regulatory News Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.” March 13, 2026Vol.52 No.10By Jacquelyn Cobb
Regulatory News CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot February 13, 2026Vol.52 No.06By Claire Marie Porter
Regulatory News FDA withdraws proposed rule for asbestos testing in talc-based cosmeticsIt’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation December 12, 2025Vol.51 No.45By Claire Marie Porter
Regulatory News ESMO publishes guidances on AI tools for clinicians, patients, and researchersSays one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.” December 12, 2025Vol.51 No.45By Sara Willa Ernst
Regulatory News Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulationsBIO calls for the end of “constant turmoil,” urges the administration to “right the ship” December 05, 2025Vol.51 No.44By Paul Goldberg
