Page 27 - Priority Review News Today

The FDA has accepted for Priority Review the sBLA supporting the conversion to full approval of Elahere for platinum-resistant ovarian cancer.

The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval.

The FDA has granted priority review to a supplemental biologics license application seeking the approval of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma.

The FDA has accepted for Priority Review the sBLA supporting the conversion to full approval of Elahere for platinum-resistant ovarian cancer.

Adaptimmune Therapeutics plc , a leader in cell therapy to treat cancer, today announced the completion of the submission of its rolling Biologics License Application to the U.S. Food and Drug...

WALTHAM - ImmunoGen, Inc. , a leader in the expanding field of antibody-drug conjugates for the treatment of cancer, today announced that the US Food and Drug Administration has filed the...

PRINCETON - Bristol Myers Squibb today announced that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application for Opdivo in combination with...

FDA accepts the sBLA for nivolumab plus cisplatin-based chemotherapy as first-line Tx for unresectable or metastatic urothelial carcinoma.

The FDA has granted Breakthrough Therapy designation to VT-X7 for the treatment of periprosthetic joint infection of the hip and knee.

UCB announces European Commission approval of ZILBRYSQ®▼ (zilucoplan) for the treatment of adults with generalized Myasthenia GravisEuropean approval of ZILBRYSQ® (zilucoplan) granted as an add-on to standard therapy for the treatment of generalized Myasthenia Gravis (gMG) in adult patients who are anti-acet...