Sanofi’s SAR446523 Gains FDA Orphan Drug Status for Relapsed or Refractory Multiple Myeloma
French pharmaceutical major Sanofi (NASDAQ: SNY) reported that the U.S. Food and Drug Administration (FDA)...
Drug
Zhaoke Ophthalmology’s Melphalan Granted FDA Orphan Drug Designation for Pediatric Retinoblastoma
China-based Zhaoke Ophthalmology Ltd (HKG: 6622), a leader in ophthalmic solutions, today announced that its...
HRAIN Biotech’s HICARA Approved by NMPA for Relapsed/Refractory LBCL
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene...
Eli Lilly’s Jaypirca Achieves Primary Endpoint in Phase III BRUIN CLL-314 Trial
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced on July 29, 2025, that...
Shanghai Pharmaceuticals’ B019 Injection Approved for SLE Clinical Trials
Shanghai Pharmaceuticals Holding Co., Ltd’s (SPH, HKG: 2607, SHA: 601607) announced that it has received...
Bayer’s Sevabertinib Granted Priority Review by China’s NMPA for NSCLC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced on July 28, 2025, that the marketing...
Huadong Medicine Receives NMPA Approval for Phase III Trial of Psoriasis Cream MC2-01
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received approval from the...
YolTech’s YOLT-203 Gains Orphan Drug Designation for Primary Hyperoxaluria Type 1 Treatment
China-based YolTech Therapeutics announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products...
Cedicine Biotech’s Umbilical Cord Blood Mononuclear Cell Injection Gains CDE Approval for Clinical Trial
China-based Cedicine Biotechnology announced today that the Center for Drug Evaluation (CDE) of the National...
Alphamab Oncology’s JSKN003 Granted FDA Orphan Drug Designation for Gastric and Gastroesophageal Junction Cancer
China-based Alphamab Oncology (HKG: 9966) announced today that its drug candidate JSKN003 has received Orphan...
Pierre Fabre’s Braftovi Approved in China for BRAF V600E-mutant Metastatic Colorectal Cancer
France-based Pierre Fabre Laboratories announced that Braftovi (encorafenib) in combination with cetuximab has been approved...
Henlius Biotech’s HLX14 Recommended for EU Approval by EMA’s CHMP
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) announced on July 28, 2025, that the European...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Type 2 Diabetes Treatment with Insulin
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced that the National Medical Products Administration...
Antengene’s XPOVIO Approved for New Multiple Myeloma Indication by China’s NMPA
China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that the China National Medical Products Administration...
BeOne Medicines’ Tislelizumab Receives Positive CHMP Opinion for NSCLC Treatment
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that its PD-1 antibody...
Bristol-Myers Squibb Gains NMPA Approval for Opdivo-Yervoy Combo in NSCLC
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that it has received another indication approval...
Roche’s Elevidys Receives Negative CHMP Opinion for Duchenne Muscular Dystrophy
Swiss giant Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced today that the Committee for Medicinal...
Aidea Pharma’s Aitribond Approved by Zanzibar Food and Drug Agency
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that its anti-HIV-1 drug Aitribond has...
Ascletis Pharma Doses First Patients in U.S. Phase 2a Trial for Monthly GLP-1 Agonist ASC30
China-based Ascletis Pharma Inc. (HKG: 1672) announced that the first participants with obesity or overweight...
Sobi North America’s Doptelet Approved by FDA for Pediatric ITP Treatment
Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today...