FDA to increase regulatory flexibility for development of cell and gene therapies

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

AstraZeneca’s application for camizestrant, a next-generation oral selective estrogen receptor degrader, or SERD, in metastatic breast cancer might have seemed set to sail smoothly through the FDA approval process.

May 08, 2026

Vol.52 No.18

By Jacquelyn Cobb

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

A version of the curriculum vitae of Vinay Prasad, an oncologist who recently departed amid controversy from a high position at FDA, contains a surprising claim.

Katherine Szarama steps in as CBER acting director, replacing Prasad

Following Vinay Prasad’s second and presumably final departure from his job as director of the Center for Biologics Evaluation and Research, Prasad’s deputy Katherine Szarama has stepped in as acting drector.

May 08, 2026

Vol.52 No.18

By Claire Marie Porter

Funding Opportunities

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

The FDA Oncology Center of Excellence (OCE) has announced a Request for Applications to support U01 cooperative agreements for Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers.

May 08, 2026

Vol.52 No.18

Drugs & Targets

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA has issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol for its experimental pancreatic cancer drug, daraxonrasib, a RAS inhibitor.

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

FDA has approved Jakafi XR (ruxolitinib) extended-release tablets for the treatment of adults with intermediateor high-risk myelofibrosis; adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease or chronic GVHD after failure of one or two lines of systemic therapy.

May 08, 2026

Vol.52 No.18

FDA to increase regulatory flexibility for development of cell and gene therapies

YOU MAY BE INTERESTED IN

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

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

Katherine Szarama steps in as CBER acting director, replacing Prasad

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

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

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

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