FDA grants Fast Track Designation to UB-VV111 in vivo CAR T-cell therapy

The evolution of cellular immunotherapy: From transplant to CAR T cells

Nearly five decades ago, I joined City of Hope’s nascent bone marrow transplant (BMT) program, which focused on improving outcomes for patients with advanced leukemia.

FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

FDA has granted a approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

October 03, 2025

Vol.51 No.36

Drugs & Targets

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

FDA has approved Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

October 03, 2025

Vol.51 No.36

Drugs & Targets

FDA publishes guidance in non-opioid pain management

FDA has published a new guidance for the development of non-opioid pain treatments in the Federal Register.

October 03, 2025

Vol.51 No.36

Podcast

With Anthony Letai’s appointment, NCI is now under new leadership—just in time for a shutdown

With little fanfare, Anthony Letai, a highly respected physician-scientist, was sworn in as the 18th director of the National Cancer Institute on Sept. 29. Then, two days later, on Oct. 1, the government shut down.

October 01, 2025

News Analysis Regulatory News

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism
Experts call the move “extremely premature”

FDA has initiated the approval of leucovorin calcium tablets, rushing them to market as part of a push from the Trump administration to identify potential treatments for autism spectrum disorder.

September 26, 2025

Vol.51 No.35

By Claire Marie Porter and Paul Goldberg

FDA grants Fast Track Designation to UB-VV111 in vivo CAR T-cell therapy

YOU MAY BE INTERESTED IN

The evolution of cellular immunotherapy: From transplant to CAR T cells

FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

FDA publishes guidance in non-opioid pain management

With Anthony Letai’s appointment, NCI is now under new leadership—just in time for a shutdown

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism
Experts call the move “extremely premature”

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FDA grants Fast Track Designation to UB-VV111 in vivo CAR T-cell therapy

YOU MAY BE INTERESTED IN

The evolution of cellular immunotherapy: From transplant to CAR T cells

FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

FDA approves Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

FDA publishes guidance in non-opioid pain management

With Anthony Letai’s appointment, NCI is now under new leadership—just in time for a shutdown

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autismExperts call the move “extremely premature”

Never miss an issue!

Login

Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism
Experts call the move “extremely premature”