Abbisko Therapeutics Secures FDA Clearance for ABSK061 Pediatric Achondroplasia Trial, Advancing Oral FGFR2/3 Inhibitor
Abbisko Therapeutics Co., Ltd. (HKG: 2256) has announced FDA clinical trial approval for its investigational...
Drug
ImmuneOnco Doses First Patient in Phase III Trial of World’s First CD47/CD20 Bispecific for Follicular Lymphoma
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) has announced the first patient dosing in a...
Merck’s Oral PCSK9 Inhibitor Enlicitide Shows Superior LDL-C Reduction in CORALreef AddOn Trial
Merck & Co., Inc. (MSD, NYSE: MRK) has disclosed detailed results from the CORALreef AddOn...
Teva Secures FDA Approval for Prolia Biosimilar Ponlimsi, Advances Xolair Copycat Through Regulatory Channels
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has announced FDA marketing approval for Ponlimsi, its biosimilar...
NMPA Approves GSK’s Exdensur as First Ultra-Long-Acting Biologic for Severe Eosinophilic Asthma
China’s National Medical Products Administration (NMPA) has approved GlaxoSmithKline plc (GSK, NYSE: GSK)’s Exdensur (depemokimab)...
Kexing Biopharma Secures FDA Clearance for GB19 Clinical Trial in Lupus, Targeting Novel BDCA2 Pathway
Kexing Biopharma (SHA: 688136) announced it has received approval from the U.S. Food and Drug...
Hansoh Pharma’s Uplizna Gains Third NMPA Approval in China for Generalized Myasthenia Gravis, Expanding CD19 Antibody Franchise
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...
Huadong Medicine’s YY001 Becomes World’s First Recombinant Botulinum Toxin Approved in China for Glabellar Lines
Huadong Medicine Co., Ltd. (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has...
AstraZeneca’s Tezspire Gains Dual NMPA Approvals in China for Severe Asthma and Nasal Polyps Based on Pivotal Phase III Data
AstraZeneca plc (NYSE: AZN) announced that China’s National Medical Products Administration (NMPA) has approved Tezspire®...
Clover Biopharmaceuticals Completes Enrollment in Phase II Trial of Trimer-Tag Respiratory Combination Vaccines for Older Adults
Clover Biopharmaceuticals Ltd. (HKG: 2197) announced the completion of subject enrollment in a Phase II...
J&J’s Darzalex SC Becomes First Oncology Injectable in Europe Approved for Patient Self-Administration
Johnson & Johnson (J&J, NYSE: JNJ) announced that the Committee for Medicinal Products for Human...
GSK’s Bepirovirsen Receives EMA Review Acceptance for Chronic Hepatitis B, Pioneering Triple-Mechanism ASO Therapy
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the European Medicines Agency (EMA) has accepted for...
AstraZeneca’s Tozorakimab Reduces COPD Exacerbations in Phase III Trials, Targeting IL-33 in First-in-Class Approach
AstraZeneca plc (NYSE: AZN) announced positive top-line results from two pivotal Phase III trials—OBERON and...
J&J’s Icotyde Sustains and Improves Complete Skin Clearance in Psoriasis Through 52 Weeks, Outperforming Deucravacitinib on Safety
Johnson & Johnson (J&J, NYSE: JNJ) released 52-week long-term data from the Phase III ICONIC-ADVANCE...
Takeda’s Zasocitinib Demonstrates Superior Efficacy Over Apremilast and Placebo in Phase III Psoriasis Trials with Unprecedented TYK2 Selectivity
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) reported positive top-line results from two pivotal...
Eli Lilly’s Taltz-Zepbound Combo Shows Superior Efficacy in Obese Psoriatic Arthritis Patients in Phase IIIb TOGETHER-PsA Trial
Eli Lilly and Company (NYSE: LLY) reported positive top-line results from the TOGETHER-PsA Phase IIIb...
Eli Lilly’s Lebrikizumab Demonstrates Four-Year Sustained Efficacy in Atopic Dermatitis, Reinforcing IL-13 as Core Therapeutic Target
Eli Lilly and Company (NYSE: LLY) reported new long-term data from an open-label extension study...
UCB’s Bimzelx Wins NMPA Approval for Two New Indications – IL-17A/F Dual-Target Antibody Expands into Psoriasis and Hidradenitis Suppurativa
UCB (EBR: UCB) announced National Medical Products Administration (NMPA) approval for Bimzelx (bimekizumab) in two...
Enhertu Wins China Approval for HER2+ Early Breast Cancer – ADC Sequential Therapy Shows 67% pCR Rate in Phase III DESTINY-Breast11
Enhertu (trastuzumab deruxtecan), the HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (NYSE: AZN) and Daiichi...
FDA Approves Rocket Pharma’s Kresladi – First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
The U.S. Food and Drug Administration (FDA) this week approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel),...