Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC)...
HER2
Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its...
Jiangsu Hengrui Pharmaceuticals Secures IND Approvals for Two Drug Candidates from China’s NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from...
AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional...
AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO:...
AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health,...
MSD Partners with IDEAYA Biosciences to Develop Combination Therapy for Endometrial Cancer
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ:...
Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals...
EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug...
Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough...
Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE:...
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...
Johnson & Johnson to Acquire Ambrx Biopharma in a Deal Valued at USD 2 Billion
Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has announced its intention to...
Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted...
Biocytogen Strikes Exclusive Licensing Deal with US-Based Radiance Biopharma for Innovative BsADC
Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a leading biopharmaceutical company based in China ,...
European Commission Expands Keytruda Indications for Advanced Cancer Treatments
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications...
HighField Biopharmaceutical Doses First Patient in HFK1 Clinical Trial Targeting Solid Tumors
Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the...
Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products...
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory...
Zymeworks and BeiGene Terminate Licensing Agreement for ZW49 ADC
Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report...