FDA rule focuses on the safety and effectiveness of LDTs

Sen. Durbin weighs in on the controversy about dosage of Amgen drug sotorasib

Sen. Richard J. Durbin (D-IL) has asked Amgen to provide copies of the company’s communications with FDA related to the dosage of Lumakras (sotorasib), a KRAS inhibitor marketed under an accelerated approval for non-small cell lung cancer.

FDA, EMA grant Orphan Drug Designation to Carthera for carboplatin with SonoCloud technology in glioma

FDA and the European Medicines Agency granted an Orphan Drug Designation to Carthera for the use of carboplatin when used with SonoCloud technology in the treatment with malignant glioma.

May 17, 2024

Vol.50 No.20

Guest Editorial

OCE’s Project 5 in 5 seeks to inspire pragmatic innovation

If the FDA Oncology Center of Excellence (OCE) began an “innovation challenge” in oncology drug development, what would that look like?

May 10, 2024

Vol.50 No.19

By Steven C. Cunningham, Donna R. Rivera, Richard Pazdur, Kelly J. Norsworthy and Jennifer Gao

Drugs & Targets

FDA accepts BLA for subcutaneous Opdivo

FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

May 10, 2024

Vol.50 No.19

Health Equity White House

Citing need for “more conversations” on menthol, White House scuttles move to ban the flavor favored by Black smokers

The Biden administration has—for the second time—delayed the decision on a proposed FDA rule that would ban menthol cigarettes and all flavors in cigars.

May 03, 2024

Vol.50 No.18

By McKenzie Prillaman

Drugs & Targets

FDA issues additional draft guidance on eligibility criteria for cancer drug clinical trials

FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.

May 03, 2024

Vol.50 No.18

FDA rule focuses on the safety and effectiveness of LDTs

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Sen. Durbin weighs in on the controversy about dosage of Amgen drug sotorasib

FDA, EMA grant Orphan Drug Designation to Carthera for carboplatin with SonoCloud technology in glioma

OCE’s Project 5 in 5 seeks to inspire pragmatic innovation

FDA accepts BLA for subcutaneous Opdivo

Citing need for “more conversations” on menthol, White House scuttles move to ban the flavor favored by Black smokers

FDA issues additional draft guidance on eligibility criteria for cancer drug clinical trials

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