FDA advances rare disease drug development with new evidence principles

After stormy Senate hearing, Trump offers tepid support for RFK Jr. while Kennedy family members call for his ouster

A fraught Senate Finance Committee hearing, where HHS Secretary Robert F. Kennedy Jr. clashed with Republicans and Democrats alike, has led to some fallout.

September 12, 2025

Vol.51 No.33

By Claire Marie Porter

Cancer Policy

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

As House committee gives NIH a small raise, cancer groups hope to maintain bipartisan support

The U.S. House Appropriations Committee has voted along party lines passing a bill that maintains current funding levels for NIH and NCI as part of its Fiscal Year 2026 Labor, HHS, Education and Related Agencies spending bill.

September 12, 2025

Vol.51 No.33

By Claire Marie Porter

Drugs & Targets

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 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

FDA advances rare disease drug development with new evidence principles

YOU MAY BE INTERESTED IN

After stormy Senate hearing, Trump offers tepid support for RFK Jr. while Kennedy family members call for his ouster

Vinay Prasad regains role as FDA chief medical and scientific officer

As House committee gives NIH a small raise, cancer groups hope to maintain bipartisan support

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

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

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