FDA approves for first denosumab biosimilars

FDA approves Breyanzi for relapsed or refractory MCL

FDA approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

May 31, 2024

Vol.50 No.22

Drugs & Targets

FDA grants accelerated approval to selpercatinib for pediatric RET-altered metastatic thyroid cancer or solid tumors

FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older

May 31, 2024

Vol.50 No.22

Drugs & Targets

FDA acknowledges BLA resubmission for Zolbetuximab for HER2- gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors

Astellas Pharma Inc. announced that FDA has acknowledged the company’s resubmission of the Biologics License Application for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.

May 31, 2024

Vol.50 No.22

Drugs & Targets

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

FDA approves for first denosumab biosimilars

YOU MAY BE INTERESTED IN

FDA approves Breyanzi for relapsed or refractory MCL

FDA grants accelerated approval to selpercatinib for pediatric RET-altered metastatic thyroid cancer or solid tumors

FDA acknowledges BLA resubmission for Zolbetuximab for HER2- gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors

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

FDA withdraws accelerated approval of infigratinib for metastatic cholangiocarcinoma with FGFR2

FDA reassigns BLA goal date for subcutaneous Opdivo

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