Priority Review Archives - Page 3 of 6

BioMarin’s BLA for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA

Diagnostic Tests, FDA, FDA/Regulatory, Hemophilia A, Priority Review

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration accepted for Priority Review the Biologics License Application to the FDA for the company’s investigational AAV5 gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

February 20, 2020/by PR Newswire

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

ALK Mutations, Biomarkers, Blockbusters, EGFR Mutations, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Non-Small Cell Lung Cancer, PD-1/PD-L1 inhibitors, Priority Review, Supplemental Biologics License Application (sBLA)

Roche Group member Genentech announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.

February 19, 2020/by Business Wire

PharmaMar and Jazz Eye Potential Approval of SCLC Drug Lurbinectedin

FDA, FDA/Regulatory, New Drug Application (NDA), Priority Review, Small cell lung cancer

The U.S. Food and Drug Administration accepted Jazz Pharmaceuticals and Spain-based PharmaMar’s New Drug Application for lurbinectedin under Priority Review.

February 17, 2020/by BioSpace

Deciphera’s GIST Treatment Earns Priority Review from FDA

FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Priority Review

The U.S. Food and Drug Administration granted Priority Review to Deciphera Pharmaceuticals’ ripretinib as an investigational treatment for advanced gastrointestinal stromal tumors (GIST).

February 13, 2020/by BioSpace

U.S. FDA Accepts For Review Astex Pharmaceuticals’ NDA For MDS Drug

FDA, FDA/Regulatory, Myelodysplastic Syndromes, Priority Review

Astex Pharmaceuticals Inc. announced that the U.S. FDA accepted for Priority Review the company’s NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk myelodysplastic syndromes, including chronic myelomonocytic leukemia.

February 11, 2020/by Business Wire

Novartis lung cancer drug gets priority U.S. review

FDA, FDA/Regulatory, Priority Review

Novartis won fast-track U.S. regulatory review for capmatinib (INC280) in a hard-to-treat form of lung cancer, the Swiss drugmaker said on Tuesday.

February 11, 2020/by Reuters Health

Zogenix Reports Positive Results from Phase III Trial of Rare Childhood Epilepsy Study

Children, Clinical Data, Clinical Trials, Dravet syndrome, European Commission, European Medicines Agency (EMA), FDA, FDA/Regulatory, Lennox-Gastaut Syndrome (LGS), New Drug Application (NDA), Orphan Drug Designation, Orphan Drug Designation, Priority Review, R&D

Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.

February 7, 2020/by BioSpace

Ahead of FDA Ruling, Genentech Releases More Positive Risdiplam Data in SMA

Clinical Data, Clinical Trials, FDA, FDA/Regulatory, Neuromuscular diseases, New Drug Application (NDA), Priority Review, R&D, Spinal Muscular Atrophy (SMA), Survival Motor Neuron 2 (SMN2) Gene

Genentech’s Risdiplam showed significant improvement in motor function in people aged 2-25 who have been diagnosed with Type 2 or 3 spinal muscular atrophy.

February 6, 2020/by BioSpace

FDA Action Alert: Alnylam and Blueprint Medicines

Acute Hepatic Porphyria (AHP), Breakthrough Therapy Designation, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Prescription Drug User-Fee Act (PDUFA), Priority Review, Sarcomas

Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.

February 3, 2020/by BioSpace

Bristol-Myers Squibb Withdraws European Application of Opdivo Plus Yervoy for First-Line Treatment of Advanced NSCLC

Blockbusters, Checkpoint Inhibitors, Committee for Medicinal Products for Human Use (CHMP), European Commission, FDA, FDA/Regulatory, PD-1/PD-L1 inhibitors, Priority Review, Withdrawn Application

Bristol-Myers Squibb withdrew the company’s application in the European Union for the combination of Opdivo and Yervoy for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.

January 31, 2020/by Business Wire