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...
Cancer
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...
MSD’s Welireg Meets Primary Endpoint in Phase III RCC Study but Misses OS Milestone
Merck, Sharp & Dohme (MSD; NYSE: MRK) has revealed that the ongoing Phase III study...
Simcere Pharmaceutical Group Secures Exclusive Rights to CMAB009 in China
Simcere Pharmaceutical Group Ltd (HKG: 2096) has announced that its subsidiary, Jiangsu Simcere Zaiming Pharmaceutical...
HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Gastric Cancer
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib),...
CytoMed Therapeutics Partners with CNK Therapeutics for CAR Gene Grafting Technology
Singapore-based cell therapy developer CytoMed Therapeutics Ltd (NASDAQ: GDTC) has announced the signing of a...
CSPC Pharmaceutical Group Receives FDA Approval for NBL-028 Bispecific Antibody Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green...
BMS Announces Positive Phase I/II Results for Repotrectinib in ROS1-Positive NSCLC
Bristol-Myers Squibb (BMS, NYSE: BMY) has released new data from a Phase I/II trial featuring...
Seagen’s Tukysa Meets Primary Endpoint in Phase III Study for HER2+ Breast Cancer
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has...
Gracell Biotechnologies Reports Q2 2023 Financials, Highlights GC012F in Melanoma Treatment
Suzhou-based biotech company Gracell Biotechnologies Inc., (NASDAQ: GRCL) has reported its financial results for the...
Gilead Sciences Enters Collaboration with Tentarix Biotherapeutics for Polyspecific Antibodies
Gilead Sciences (NASDAQ: GILD) has announced the initiation of three collaboration programs with US-based Tentarix...