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...
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...
Rossum Robot’s Intelligent Surgical Robot for Trauma and Spinal Surgery Clears NMPA Approval
Rossum Robot, a Beijing-based developer of orthopedic surgical robots specializing in pelvic fracture procedures, has...
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...
AbbVie CEO Rick González to Retire, Succeeded by Robert A. Michael
AbbVie (NYSE: ABBV), a leading US pharmaceutical company, has announced that Rick González, who has...
Sinopharm Plans to Privatize China Traditional Medicine Holdings in a USD 2 Billion Deal
China Traditional Medicine Holdings (HKG: 0570; China TCM) has announced that its controlling shareholder, the...
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...
Zylox-Tonbridge Receives UAE Approval for Five Medical Devices, Expands Middle East Presence
Zylox-Tonbridge (HKG: 2190), a Chinese specialist in medical devices, has announced a series of product...
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;...
CDE Opens Consultation on 79th Batch of Generic Drug Reference Preparations
The Center for Drug Evaluation (CDE) has issued a call for feedback on the 79th...
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...
AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca...
FDA Issues Warning Letter to Sichuan Deebio for cGMP Violations in API Manufacturing
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Sichuan Deebio...
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)...