FDA grants Fast Track designation for CER-1236 in AML

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.

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

FDA has approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

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 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