priority review
FDA grants accelerated approval for advanced non-small cell lung cancer treatment
July 4, 2025Medical 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 …
FDA approves Incyte’s new anal cancer treatment
May 20, 2025Research 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 …
NDA in China receives priority review status for lung cancer treatment
January 3, 2025Research 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 …
FDA accepts Atara Biotherapeutics’ Tab-Cel for priority review
July 18, 2024Medical 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 …
Sanofi’s Sarclisa accepted for FDA priority review
May 29, 2024Medical 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 …
FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review
February 22, 2024Medical 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 …
FDA Priority Review for Pfizer investigational leukaemia drug
February 22, 2017Research 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 …
Roche’s Actemra granted Priority Review by FDA
January 24, 2017Manufacturing 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 …
Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis
June 28, 2016Manufacturing 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 …
Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer
March 15, 2016Manufacturing 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 …
FDA grants Eisai’s Lenvima priority review for kidney cancer
January 19, 2016Manufacturing 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 …
