Sanofi Secures CHMP Positive Opinion for Cenrifki (Tolebrutinib) in Non-Relapsing SPMS Despite FDA Complete Response Letter Setback
Sanofi (NASDAQ: SNY) announced on 24 April 2026 that the European Medicines Agency’s Committee for...
Drug
Novartis Withdraws Pluvicto Pre-Chemotherapy mCRPC Application in EU Following CHMP Objections on PSMAfore Control Arm Design
Novartis AG (NYSE: NVS) announced the voluntary withdrawal of its Type II variation application to...
AstraZeneca Secures Dual NMPA Approvals for Imfinzi-Based Regimens in Advanced Hepatocellular Carcinoma and NSCLC
AstraZeneca plc (NYSE: AZN) announced that China’s National Medical Products Administration (NMPA) has granted approvals...
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...
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Simcere Pharmaceutical Group Limited (HKG: 2096) has withdrawn its New Drug Application (NDA) for rademikibart...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...