FDA grants Ambrx Fast Track designation for prostate cancer ADC therapy

USC study identifies mutations in 11 genes associated with aggressive prostate cancer

USC Norris Comprehensive Cancer Center has singled out mutations in 11 genes that are associated with aggressive forms of prostate cancer.

September 22, 2023

Vol.49 No.35

Drugs & Targets

FDA grants Merck sBLA priority review for Keytruda + chemoradiotherapy in cervical cancer

FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk, locally advanced cervical cancer.

September 22, 2023

Vol.49 No.35

Funding Opportunities

FDA opens application for Orphan Products Clinical Trials Grant Program

FDA is accepting applications for its Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01). This program is administered by the FDA’s Office of Orphan Products Development.

September 15, 2023

Vol.49 No.34

Drugs & Targets

FDA approves Akeega for BRCA-positive metastatic castration-resistant prostate cancer

FDA approved Akeega (niraparib and abiraterone acetate), a dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.

September 15, 2023

Vol.49 No.34

Clinical Roundup

City of Hope researchers identify biomarkers that may detect risk of advanced prostate cancer in Black men

Scientists at City of Hope have identified a cell metabolism process found in men with diabetes and metastatic prostate cancer that could one day lead to improved testing and treatments for Black men with these diseases.

September 08, 2023

Vol.49 No.33

Drugs & Targets

FDA grants accelerated approval to Elrexfio for r/r multiple myeloma

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

September 08, 2023

Vol.49 No.33

FDA grants Ambrx Fast Track designation for prostate cancer ADC therapy

YOU MAY BE INTERESTED IN

USC study identifies mutations in 11 genes associated with aggressive prostate cancer

FDA grants Merck sBLA priority review for Keytruda + chemoradiotherapy in cervical cancer

FDA opens application for Orphan Products Clinical Trials Grant Program

FDA approves Akeega for BRCA-positive metastatic castration-resistant prostate cancer

City of Hope researchers identify biomarkers that may detect risk of advanced prostate cancer in Black men

FDA grants accelerated approval to Elrexfio for r/r multiple myeloma

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