Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it...
Drug
Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that...
AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial...
Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P...
FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen...
Immune-Onc Therapeutics’ IO-202 Earns Orphan Drug Designation for CMML from US FDA
Immune-Onc Therapeutics, the Hangzhou-based subsidiary of US company Immune-Onc Therapeutics Inc., has announced that it...
Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that...
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;...
Zhongsheng Pharmaceutical Initiates Phase II Trials for Polypeptide Drug RAY1225 in Diabetes and Obesity
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced the initiation...
Bayer Advances BAY3018250 into Phase II Trial Following Successful Phase I Completion
Germany’s Bayer (ETR: BAYN) has launched a double-blind, placebo-controlled mid-stage trial for its potential first-in-class...
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....
WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG:...
HitGen’s Vernalis Partners with Hox Therapeutics to Develop Novel Cancer Inhibitors
HitGen Inc. (SHA: 688222), based in China, announced that its wholly owned subsidiary Vernalis (R&D)...
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...
Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval...
Neurophth Biotechnology Completes Enrollment and Dosing in US Clinical Study for ND4-LHON Gene Therapy
Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced the completion...
Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval...
ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based...
AstraZeneca’s Tagrisso Wins Expanded FDA Approval for EGFR-mutated NSCLC
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has received a new indication approval from the...