FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

FDA issues warning letter to ImmunityBio over misleading claims about cancer drug

ImmunityBio and its owner and executive chairman Patrick Soon-Shiong received a warning letter from FDA for making false and misleading claims about a cancer treatment in television ads and on a podcast.

March 27, 2026

Vol.52 No.12

By Claire Marie Porter

Cancer Policy

FDA withdraws proposed rule that would have banned minors from using tanning beds

FDA, with support from HHS Secretary Robert F. Kennedy Jr., is scrapping a proposed rule that would have banned people under 18 from using tanning beds.

March 27, 2026

Vol.52 No.12

By Claire Marie Porter

Cancer Policy

FDA issues draft guidance to reduce animal testing

FDA has published a draft guidance to incentivize drug developers to use and validate new approach methodologies, or NAMS, as part of a broader effort to move away from animal testing.

March 27, 2026

Vol.52 No.12

By Claire Marie Porter

Drugs & Targets

FDA and EC approve Opdivo IO combinations in classical Hodgkin Lymphoma

FDA granted approval of Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated Stage 3 or 4 classical Hodgkin Lymphoma.

March 27, 2026

Vol.52 No.12

Drugs & Targets

FDA approves relacorilant + nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

FDA approved relacorilant (Lifyorli), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

March 27, 2026

Vol.52 No.12

Drugs & Targets

FDA approves label update to accelerate thaw time for Adstiladrin gene therapy for NMIBC

FDA approved a label update that will accelerate thaw time for Adstiladrin (nadofaragene firadenovec-vncg), gene therapy for adults with high-risk, BCG-unresponsive non-muscle invasive bladder cancer, enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams.

March 27, 2026

Vol.52 No.12

FDA grants priority review to HER2-directed therapy as first-line treatment of HER2-positive metastatic breast cancer

YOU MAY BE INTERESTED IN

FDA issues warning letter to ImmunityBio over misleading claims about cancer drug

FDA withdraws proposed rule that would have banned minors from using tanning beds

FDA issues draft guidance to reduce animal testing

FDA and EC approve Opdivo IO combinations in classical Hodgkin Lymphoma

FDA approves relacorilant + nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

FDA approves label update to accelerate thaw time for Adstiladrin gene therapy for NMIBC

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