Amgen’s Uplizna Approved by FDA for IgG4-Related Disease
US biotech giant Amgen (NASDAQ: AMGN) announced that it has received marketing approval from the...
Drug
J&J’s Rybrevant SC Formulation Approved by EC for NSCLC Treatment
The European Commission (EC) has approved the subcutaneous (SC) formulation of Johnson & Johnson’s (J&J,...
J&J’s Darzalex SC Formulation Approved for Newly Diagnosed Multiple Myeloma
Johnson & Johnson (J&J, NYSE: JNJ) announced that it has received clearance from the European...
AIM Vaccine’s Serum-Free Rabies Vaccine Accepted for Review by NMPA
China-based AIM Vaccine Co., Ltd (HKG: 6660) announced that its market filing for a serum-free...
SinoMab BioScience’s SM17 Shows Promising Results in Phase Ib Atopic Dermatitis Study
Hong Kong-based biotech SinoMab BioScience Ltd (HKG: 3681) has announced positive results from the Phase...
Luye Pharma’s Toludesvenlafaxine Approved for Marketing in Macau
China-based Luye Pharma Group (HKG: 2186) announced that its extended-release depression treatment, toludesvenlafaxine (LY03005), has...
Shanxi Yanghe Medical Technology Faces Production Halt Over GMP Violation
China’s National Drug Alliance Procurement Office has imposed manufacturing suspensions on Shanxi Yanghe Pharmaceutical Technology’s...
Hansoh Pharmaceutical Secures Dual NMPA Approvals for Oncology Pipeline Expansion
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving dual clinical trial approvals...
Huadong Medicine’s DR30206 Approved for Clinical Trials in Gastrointestinal Tumors
China-based Huadong Medicine Co., Ltd. (SHE: 000963) announced that it has received clinical trial approval...
Phanes Therapeutics Gains CDE Approval for Peluntamig Phase II Trial in SCLC and NEC
Sino-US biotech Phanes Therapeutics Inc. announced receiving approval from the Center for Drug Evaluation (CDE)...
Suzhou Ribo Life Science Completes Enrollment for Phase IIa Study of FXI-Targeted siRNA Drug RBD4059
China-based Suzhou Ribo Life Science Co., Ltd announced the completion of subject enrollment for the...
Nanjing King-Friend Bio’s Biosimilar Victoza Approved by FDA
China-based Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (SHA: 603707) announced that its Abbreviated New Drug...
Bio-Sincerity Pharma-tech Gains NMPA Approval for BIOS-0618 in Obstructive Sleep Apnea
Hangzhou Bio-Sincerity Pharma-tech Corp., Ltd (SHE: 301096) has secured clinical trial approval from China’s National...
Santen’s Tapcom Approved by China’s NMPA for Glaucoma Treatment
Japan-based Santen Pharmaceutical Co., Ltd. announced that it has received marketing approval from China’s National...
Enhertu Approved by EC for Earlier-Line Treatment of HR+/HER2-low Breast Cancer
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval...
Sino Biopharmaceutical’s TQB2101 Receives NMPA Approval for Phase I Trial in Advanced Malignancies
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has received approval from the National...
Hengrui Pharmaceuticals Gains NMPA Approval for HRS-6719 in Solid Tumors
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received clinical trial...
Sanofi’s Rilzabrutinib Granted Orphan Drug Designation for Rare Diseases
Sanofi (EPA: SAN, NASDAQ: SNY) announced that it has received Orphan Drug Designation (ODD) from...
Sunshine Guojian’s SSGJ-627 Gains NMPA Approval for Ulcerative Colitis Trial
China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG:...
Sarepta and Roche Seek to Resume Elevidys Trials After EMA Halt
The European Medicines Agency (EMA) may lift the temporary hold on certain Phase III studies...