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Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC
Regulatory News

Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC

May 08, 2026
Vol.52 No.18
By Jacquelyn Cobb
Vinay Prasad’s CV inaccurately claims past membership on the President’s Cancer Panel

Vinay Prasad’s CV inaccurately claims past membership on the President’s Cancer Panel

May 08, 2026
Vol.52 No.18
By Paul Goldberg
Katherine Szarama steps in as CBER acting director, replacing Prasad
Cancer Policy

Katherine Szarama steps in as CBER acting director, replacing Prasad

May 08, 2026
Vol.52 No.18
By Claire Marie Porter
Funding Opportunities

FDA’s OCE announces funding opportunity in ultra-rare cancers

May 08, 2026
Vol.52 No.18
Drugs & Targets

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

May 08, 2026
Vol.52 No.18
By Claire Marie Porter
Drugs & Targets

FDA approves Jakafi XR tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease

May 08, 2026
Vol.52 No.18
Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time
Podcast

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

May 06, 2026
FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
Regulatory News

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

May 01, 2026
Vol.52 No.17
By Sara Willa Ernst
Drugs & Targets

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

May 01, 2026
Vol.52 No.17
By Jacquelyn Cobb
Drugs & Targets

FDA accepts NDA for zipalertinib for NSCLC with mutations

May 01, 2026
Vol.52 No.17

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