MSD MK-2214 Fast Track Alzheimer Data Positive
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) released first‑in‑human data for MK-2214 and MK-1167 in...
Drug
Generate GB-0895 Asthma Phase III Trials to Enroll 1,600 Patients
Generate: Biomedicines today announced plans to initiate two global Phase III clinical trials (SOLAIRIA-1 and...
Henlius HLX14 Denosumab Biosimilar NDA Accepted by China CDE
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the National Medical Products Administration’s Center for...
Kura ziftomenib Sale Triggers $135M Kyowa-Kirin Payment
Kura Oncology, Inc. (NASDAQ: KURA) announced completion of the first US commercial sale of KOMZIFTI...
Henlius HLX37 Bispecific NMPA Approval Targets Advanced Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its self-developed investigational new drug, HLX37 (Recombinant...
Leads-Biolabs LBL047 Bispecific Secures China IND Approval for SLE
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that the National Medical Products Administration (NMPA)...
Abbisko ABSK141 KRAS-G12D Inhibitor Secures FDA IND Approval
Abbisko Cayman Limited (HKG: 2256) announced that its Investigational New Drug (IND) application for ABSK141,...
AbbVie Rinvoq upadacitinib CDE Priority Review Alopecia Areata China
AbbVie (NYSE: ABBV) announced that Rinvoq (upadacitinib) has been included in the priority review list...
Lynk Pharma LNK01006 FDA Approval Targets TYK2 for CNS Diseases
Lynk Pharmaceuticals Co., Ltd. announced that its self‑developed TYK2 allosteric inhibitor LNK01006 has received FDA...
CANbridge’s maralixibat Wins Hong Kong Approval for PFIC Cholestatic Pruritus
CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that maralixibat has been approved by the Department of...
Johnson & Johnson’s Nipocalimab Secures EU Approval for Myasthenia Gravis
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission has granted Marketing Authorisation...
Humanwell’s HWS117 Long-Acting FSH Secures NMPA Clinical Trial Approval for Assisted Reproduction
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its Class 1 biological product HWS117 injection...
Mabwell’s 9MW1911 Cuts COPD Exacerbations by 30% in Phase 2a, FDA Accepts US Trial Application
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its ST2‑blocking monoclonal antibody 9MW1911 has...
Imugene and JW Therapeutics Partner to Evaluate onCARlytics CAR‑T Combination for Advanced Solid Tumors
Imugene Ltd (ASX: IMU) and JW Therapeutics (Shanghai) Co., LTD (HKG: 2126) announced a co‑development...
iRegene’s NouvNeu004 Wins FDA Special Exemption for MSA Cell Therapy
iRegene Therapeutics announced that the U.S. FDA granted Special Exemption status to NouvNeu004 injection, approving...
Pfizer-Astellas’ PADCEV Wins FDA Approval for Perioperative Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food...
GenSci’s GenSci142 Wins NMPA Nod for Bacterial Vaginosis Clinical Trials
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary GenSci...
Jiuzhou Pharmaceutical Wins Tentative FDA Approval for Generic Janumet XR
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (SHA: 603456) announced that its Abbreviated New Drug Application (ANDA)...
Hengrui’s Ivarmacitinib Wins NMPA Nod for Vitiligo Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that Ivarmacitinib Tablets and SHR0302...