China Medical System’s Comekibart Anti-IL-4Rα Antibody Enters NMPA Review for Seasonal Allergic Rhinitis
China Medical System Holdings Limited (CMS; HKG: 0867) announced that the National Medical Products Administration...
Drug
AbbVie Receives FDA Complete Response Letter for TrenibotE with Manufacturing Clarifications Requested
AbbVie Inc. (NYSE: ABBV) disclosed on April 23, 2026, that it has received a Complete...
Regeneron Secures FDA Approval for Otarmeni Gene Therapy and Announces Landmark U.S. Pricing Agreement
Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
Transcenta Presents Promising Pre-clinical Data for Proprietary LIV1 Antibody-Drug Conjugate at AACR 2026
Transcenta Holdings Ltd (HKG: 6628) has presented pre-clinical data for its proprietary LIV1 antibody-drug conjugate...
Simcere Pharmaceutical Withdraws NDA for Rademikibart in Atopic Dermatitis, Plans Resubmission Later This Month
Simcere Pharmaceutical Group Limited (HKG: 2096) has withdrawn its New Drug Application (NDA) for rademikibart...
Kangtai Biological Initiates Phase I Clinical Study for Trivalent Influenza Split Vaccine Produced in MDCK Cells
Shenzhen Kangtai Biological Products Co., Ltd. (SHE: 300601) has announced the initiation of a single-center,...
FDA Expands Sanofi’s Tzield Approval to Children as Young as One Year Old for Type 1 Diabetes Prevention
The U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application for...
European Commission Grants Conditional Approval to Ipsen’s Ojemda (Tovorafenib) for Pediatric Low-Grade Glioma with BRAF Alterations
Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced on April 22, 2026, that the European Commission...
FDA Approves Sanofi-Regeneron’s Dupilumab for Pediatric Chronic Spontaneous Urticaria in Children Aged 2–11 Years
The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi (NASDAQ: SNY) and...
China’s CDE Releases 106th Batch of Chemical Generic Reference Preparations with 27 New Specifications and Updated Guidelines
The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration has published the...
FDA Extends Review Timeline for Sanofi’s Sarclisa Subcutaneous Formulation by Three Months; New Decision Date Set for July 23, 2026
The U.S. Food and Drug Administration (FDA) has extended the target action date for its...
Merck’s Idvynso Gains FDA Approval as Novel Dual-Drug HIV Treatment
Merck & Co., Inc. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration...
Roche’s Fenebrutinib Slashes MS Relapse Rates by Over 50% in Phase III Trials
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that its investigational non-covalent Bruton’s tyrosine kinase (BTK)...
Gan & Lee’s Nectin-4 ADC GLR1059 Clears Regulatory Hurdle for Solid Tumor Trials
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced it has received approval from China’s...
Leads Biolabs Enrolls First Patient in Phase II Trial for Gastric Cancer Drug Opamtistomig
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced the first patient enrollment in a Phase...
Roche’s Gazyva Gains FDA Review Acceptance for Systemic Lupus Erythematosus Treatment
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
Daiichi Sankyo and AstraZeneca Launch Datroway ADC in China for HR-Positive, HER2-Negative Breast Cancer
Daiichi Sankyo Co., Ltd. (TYO: 4568) and AstraZeneca plc (NYSE: AZN) announced the commercial launch...
Merck and Eisai’s LITESPARK-012 Trial Fails to Meet Primary Endpoints in Advanced Kidney Cancer
Merck & Co., Inc. (MSD, NYSE: MRK) and Eisai Co., Ltd. (TYO: 4523) announced that...
AstraZeneca’s Ultomiris Shows Significant Proteinuria Reduction in Phase III IgA Nephropathy Trial
AstraZeneca plc (NYSE: AZN) announced positive results from a pre-specified interim analysis of the Phase...
CSPC’s Albumin-Bound Sirolimus (HB1901) Meets Primary Endpoint in Phase Ib/III Trial for Rare PEComa, Reinforcing Breakthrough Therapy Status
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that its pivotal Phase Ib/III clinical trial of...