Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension...
Cancer
Antengene’s Xpovio Price Reduced by 37% in China, Aiding Patient Access
Antengene Corp., Ltd (HKG: 6996) has announced a significant price reduction for its drug Xpovio...
GenFleet Therapeutics and Verastem Oncology Ink Licensing Deal for RAS Pathway Cancer Therapies
China-based GenFleet Therapeutics has entered into an exclusive licensing and early development agreement with US...
Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review...
Tasly Pharmaceuticals Gets NMPA Approval for STRO-002 Clinical Study in Solid Tumors
China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National...
AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and...
Akeso Biopharma’s Ivonescimab Heads for Priority Review for NSCLC Treatment
China-based Akeso Biopharma (HKG: 9926) has announced that its bispecific antibody (BsAb) ivonescimab (AK112), targeting...
Dizal Pharmaceutical’s Sunvozertinib Approved by China’s NMPA for NSCLC Treatment
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that it has received market approval...
Hinova Pharmaceuticals’ HP518 for mCRPC Accepted for Review by China’s NMPA
Chengdu-based biotech company Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the National Medical Products...
Eli Lilly’s Retevmo Meets Primary Endpoint in Phase III Trial for RET-mutant Medullary Thyroid Cancer
Eli Lilly (NYSE: LLY) has announced that its Phase III trial for the RET kinase...
FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
The US Food and Drug Administration (FDA) has granted priority review status to the submission...
Allist Pharmaceuticals’ Furmonertinib Wins NMPA Nod for EGFR-Mutated NSCLC Treatment
Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced that it has received clinical approval from...
Zai Lab’s Repotrectinib Targets Breakthrough Therapy Designation for TRK-Positive Tumors
The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine...
Roche Subsidiary Genentech Addresses Accidental Disclosure of Tiragolumab Trial Data
Swiss pharmaceutical major Roche (SWX: ROG), through its subsidiary Genentech, has released a statement addressing...
European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ)...
Novatim’s KQ-2003 and KY-0118 Advance with Clinical Trial Approvals in China
China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd has recently obtained clinical trial...
Lifetech Scientific Corporation Receives NMPA Approval for Epione Navigation System
China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received market approval from...
Gilead’s Magrolimab Phase III Trial for AML Faces Partial Hold by FDA
Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration (FDA) has imposed...
J&J’s Teclistamab Granted Priority Review in China for Relapsed Multiple Myeloma
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE:...
Amgen’s Lumakras Faces Full Registration Review by FDA for KRAS-Mutated NSCLC
The US Food and Drug Administration (FDA) is scheduled to review an application submitted by...