J&J Darzalex Faspro Gets NMPA Approval for Transplant-Eligible Myeloma Patients
Johnson & Johnson (J&J, NYSE: JNJ) announced that Darzalex Faspro (daratumumab and hyaluronidase-fihj) has received National...
Drug
Everest Medicines Files Velsipity for Ulcerative Colitis in China
Everest Medicines (HKG: 1952) announced it has submitted a marketing filing in China for Velsipity...
Keytruda Wins 20th China Approval for Endometrial Cancer in First-Line Setting
Merck & Co. (MSD, NYSE: MRK) announced that Keytruda (pembrolizumab) has received its 20th indication approval...
Hanx Biopharma HX111 ADC Begins Phase I Trial for Lymphoma and Solid Tumors
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (HKG: 3378) announced the initiation of a Phase I clinical...
Shouyao’s SY-9453 MAT2A Inhibitor Gets NMPA Nod for MTAP-Deleted Tumors
Shouyao Holdings (Beijing) Co., Ltd. (SHA: 688197) announced that the National Medical Products Administration (NMPA)...
Huadong Medicine DR10624 Gets NMPA Nod for Hypertriglyceridemia Study
Huadong Medicine Co., Ltd (SHE: 000963) announced that its subsidiary Doer Biologics has received National...
AstraZeneca Saphnelo Faces FDA Setback with Complete Response Letter
AstraZeneca (AZ, NASDAQ: AZN) announced it has received a Complete Response Letter (CRL) from the U.S....
Hualan Biological’s HL08 GLP-1 Drug Gets NMPA Nod for Obesity Trial
Hualan Biological Engineering Inc. (SHE: 002007) announced that the National Medical Products Administration (NMPA) has...
Marubeni Launches Xenleta in China After Complex Licensing Journey
Marubeni Pharmaceuticals (China) Co., Ltd. (formerly Sumitomo Pharma China) announced the initiation of commercialization for...
CMS-D017 Gets NMPA Approval for Complement-Mediated Kidney Disease Study
China Medical System Holdings Limited (HKG: 0867) announced that the National Medical Products Administration (NMPA) has...
Akeso Licenses Yixining to Jumpcan for PCSK9 Promotion in China
Akeso Biopharma (HKG: 9926) announced a partnership with Jumpcan Pharmaceutical (SHA: 600566) granting Jumpcan exclusive...
United Laboratories UBT251 Gets NMPA Nod for Sleep Apnea Trial
United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has...
Wuhan YZY Biopharma Gets FDA Nod for M701 Phase Ib/II MPE Study
Wuhan YZY Biopharma Co., Ltd (HKG: 2496) announced that the U.S. Food and Drug Administration...
BeBetter Med BEBT-701 Approved for Hypertension siRNA Trial
Guangzhou BeBetter Medicine Technology Co., Ltd. (SHA: 688759) announced that the National Medical Products Administration...
AbbVie Files Rinvoq for Vitiligo Approval in US and EU
AbbVie (NYSE: ABBV) announced it has submitted new indication applications to the U.S. Food and Drug...
Datroway TNBC sBLA Gets FDA Priority Review for Triple-Negative Breast Cancer
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug Administration...
Bayer Nubeqa Gets NMPA Approval for Metastatic Prostate Cancer
Bayer AG (ETR: BAYN) announced that the National Medical Products Administration (NMPA) has approved Nubeqa (darolutamide)...
Venglustat Gaucher: Sanofi Meets Primary Endpoint in Phase 3 LEAP2MONO Study
Sanofi (NASDAQ: SNY) announced positive results from the LEAP2MONO phase 3 study (NCT05222906), showing venglustat met the...
Eli Lilly Mounjaro Fails to Win EU Approval for HFpEF Heart Failure Indication
Eli Lilly (NYSE: LLY) announced that the European Medicines Agency (EMA) drug advisory panel declined to...
Imfinzi Gastric Cancer: AstraZeneca Secures CHMP Recommendation
AstraZeneca (AZ, NASDAQ: AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) has...