Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone...
Priority reviews
Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for...
Guangzhou and Zhuhai Unveil Measures to Stimulate Biopharmaceutical Industry Growth
In a bid to bolster the biopharmaceutical and health industries, the cities of Guangzhou and...
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...
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...