Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has...
Priority reviews
J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ)...
Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio...
Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics...
Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed...
BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY)...
Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an...
J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ)...
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart...
Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food...
MSD’s Belzutifan and Sperogenix’s Vamorolone Targeted for Priority Review by China’s CDE
The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD;...
BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S....
Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
This week, the U.S. FDA granted priority review status to an indication extension filing from...
FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK;...
AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for...
Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
The US Food and Drug Administration (FDA) has concluded a priority review and granted approval...
Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
The US Food and Drug Administration (FDA) has accepted for priority review a filing from...
Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is...
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
The US Food and Drug Administration (FDA) has accepted under priority review a filing from...
InventisBio’s KRAS G12C Inhibitor D-1553 Advances Toward Priority Review in China
According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382)...