Linvoseltamab BLA accepted for Priority Review for R/R multiple myeloma

FDA advisory committee recommends approval of Shield blood test for colorectal cancer screening

FDA’s Medical Devices Advisory Committee has strongly recommended FDA approval of Guardant Health’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.

May 24, 2024

Vol.50 No.21

Drugs & Targets

FDA withdraws accelerated approval of infigratinib for metastatic cholangiocarcinoma with FGFR2

FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.

May 24, 2024

Vol.50 No.21

Drugs & Targets

FDA reassigns BLA goal date for subcutaneous Opdivo

FDA has reassigned the previously announced Prescription Drug User Fee Act goal date of Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20).

May 24, 2024

Vol.50 No.21

Drugs & Targets

FDA forms OCE Equity Program to improve clinical trial access

FDA Oncology Center of Excellence has formed the OCE Equity Program.

May 24, 2024

Vol.50 No.21

Capitol Hill

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

Linvoseltamab BLA accepted for Priority Review for R/R multiple myeloma

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FDA reassigns BLA goal date for subcutaneous Opdivo

FDA forms OCE Equity Program to improve clinical trial access

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

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