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priority review

Showing 11 posts of 11 posts found.

FDA grants accelerated approval for advanced non-small cell lung cancer treatment

July 4, 2025
Medical Communications, Research and Development Breakthrough Therapy Designation, Oncology, US Food and Drug Administration, Zegfrovy, clinical trial, non-small cell lung cancer, priority review

The US Food and Drug Administration (FDA) has granted accelerated approval to Dizal Therapeutic’s Zegfrovy (sunvozertinib) for the treatment of …

News

FDA approves Incyte’s new anal cancer treatment

May 20, 2025
Research and Development FDA, Incyte Corporation, Oncology, Orphan Drug Designation (ODD), Zynyz, fast track designation, priority review

The US Food and Drug Administration (FDA) has approved Incyte Corporation’s immunotherapy retifanlimab-dlwr (Zynyz) in combination with carboplatin and paclitaxel to treat …

News

NDA in China receives priority review status for lung cancer treatment

January 3, 2025
Research and Development China, China National Medical products Administration, HUTCHMED, NDA, Oncology, epidermal growth factor receptor, non-small cell lung cancer, priority review

HUTCHMED have announced that the China National Medical Products Administration (NMPA) have granted a priority review for a new drug …

News

FDA accepts Atara Biotherapeutics’ Tab-Cel for priority review

July 18, 2024
Medical Communications Atara Biotherapeutics, FDA, Virology, priority review

Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License …

News

Sanofi’s Sarclisa accepted for FDA priority review

May 29, 2024
Medical Communications FDA, Oncology, Sanofim, Sarclisa, multiple myeloma, priority review

Sanofi has announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for …

News

FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review

February 22, 2024
Medical Communications FDA, Oncology, Regeneron, bla, priority review

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for …

News

FDA Priority Review for Pfizer investigational leukaemia drug

February 22, 2017
Research and Development, Sales and Marketing EMA, FDA, Inotuzumab ozogamicin, Pfizer, priority review

Pfizer has announced that its leukaemia treatment inotuzumab ozogamicin has been accepted for Priority Review by the US Food and …

News
roche_close

Roche’s Actemra granted Priority Review by FDA

January 24, 2017
Manufacturing and Production, Sales and Marketing Actemra, FDA, Roche, priority review

Roche’s drug, Actemra (also known as RoActemra in Europe), has been granted priority review designation by the FDA for the …

News

Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation

Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …

News

Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer

March 15, 2016
Manufacturing and Production, Research and Development FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review

The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease …

News
Eisai logo

FDA grants Eisai’s Lenvima priority review for kidney cancer

January 19, 2016
Manufacturing and Production Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma

The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment …

News
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