FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

Vinay Prasad regains role as FDA chief medical and scientific officer

Vinay Prasad has regained his role as FDA’s chief medical and scientific officer, according to an update on the agency’s website.

September 12, 2025

Vol.51 No.33

By Claire Marie Porter

Cancer Policy

FDA advances rare disease drug development with new evidence principles

FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.

Padcev + Keytruda reach primary endpoint for some bladder cancers, phase III trial shows

Pacdev (enfortumab vedotin), in combination with PD-1 inhibitor Keytruda (pembrolizumab), reached the main goals in a late-stage trial for certain patients with bladder cancer.

September 12, 2025

Vol.51 No.33

Drugs & Targets

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

FDA granted Breakthrough Therapy designation to Hernexeos (zongertinib tablets) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations.

September 12, 2025

Vol.51 No.33

Drugs & Targets

FDA grants Fast Track designation for CER-1236 in AML

FDA has granted Fast Track designation to CER-1236 for Acute Myeloid Leukemia. CER-1236 is a therapy that engineers a cancer patient’s own T-cell therapeutics that deploy phagocytic mechanisms alongside the array of built-in target cell destroying mechanisms used by T-cells.

September 12, 2025

Vol.51 No.33

Drugs & Targets

FDA seeks academic and patient advocate research partners for oncology data analysis

The FDA’s Oncology Center of Excellence is inviting academic and patient advocate researchers to propose research questions for Project Collaborate, a crowdsourcing initiative running Sept. 2-26.

September 12, 2025

Vol.51 No.33

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

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Vinay Prasad regains role as FDA chief medical and scientific officer

FDA advances rare disease drug development with new evidence principles

Padcev + Keytruda reach primary endpoint for some bladder cancers, phase III trial shows

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

FDA grants Fast Track designation for CER-1236 in AML

FDA seeks academic and patient advocate research partners for oncology data analysis

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