Page 41 - Priority Review News Today

/PRNewswire/ -- Dizal announced today that the China National Medical Products Administration (NMPA) has granted priority review status to golidocitinib,...

Product sales more than doubled in the first half of 2023 to €69.7 million compared to €33.3 million in the first half of 2022 Driven by IXIARO® and DUKORAL® sales, both of which benefited from a continued

Pembrolizumab plus chemoradiotherapy is under priority review for newly diagnosed, high-risk, locally advanced cervical cancer.

The FDA has granted priority review to a supplemental biologics license application seeking the approval of pembrolizumab in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, for the treatment of newly diagnosed patients with high-risk, locally advanced cervical cancer.

Pembrolizumab plus chemoradiotherapy is under Priority Review for newly diagnosed patients with high-risk locally advanced cervical cancer.

The FDA has accepted for Priority Review the sNDA for belzutifan for the treatment of adults with advanced renal carcinoma following immune checkpoint and anti-angiogenic therapies.

The FDA has accepted for Priority Review the BLA for OTL-200 for the treatment of metachromatic leukodystrophy.

Iovance Biotherapeutics, Inc. announced the U.S. Food and Drug Administration , because of resource constraints, requires additional time to complete the Priority Review of Iovances Biologics License...

Thursday, the FDA extended the review period for Iovance Biotherapeutics Inc's (NASDAQ: IOVA) marketing application seeking accelerated approval for lifileucel 

15.09.2023 - Priority Review Continues with Successful Facility Inspections Completed,no Major Review Issues FDA Extends PDUFA Date to February 24, 2024 on Resource Constraints and Agrees to Work with Iovance to Expedite Remaining Review SAN CARLOS, Calif., ... Seite 1