Neurocrine Biosciences to Acquire Soleno Therapeutics for $2.9 Billion, Adding Three First-in-Class Commercial Assets
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) has announced a definitive agreement to acquire fellow U.S. biopharmaceutical...
Rare / orphan disease drugs
Amgen’s Subcutaneous Tepezza via On-Body Injector Meets Phase III Endpoint in Thyroid Eye Disease with 77% Proptosis Response
Amgen Inc. (NASDAQ: AMGN) announced positive top-line results from a Phase III clinical trial evaluating...
Rui Therapeutics Secures NMPA Approval for KN5501 CAR-NK Therapy in Autoimmune Diseases
Rui Therapeutics, a China-based cell therapy developer, announced it has received approval from the National...
Changchun High & New Receives NMPA Approval for GenSci161 Clinical Study in Endometriosis and Hidradenitis Suppurativa
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced it has received approval...
Biogen Secures FDA Approval for High-Dose Spinraza Regimen in Spinal Muscular Atrophy
Biogen Inc. (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved...
Abbisko Therapeutics Secures EMA Orphan Drug Designation for Irpagratinib in Hepatocellular Carcinoma
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the European Medicines Agency (EMA) has granted...
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...
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)...
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...
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),...
Pulmongene’s PMG1015 Wins FDA Fast Track Designation – First-in-Class AREG Antibody Targets Idiopathic Pulmonary Fibrosis
Pulmongene (Beijing) Ltd. announced that PMG1015 received Fast Track Designation (FTD) from the U.S. Food...
Changchun High-Tech Wins FDA Orphan Drug Designation for GenSci128 – TP53 Y220C Reactivator Targets Gastric Cancer
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that GenSci128 received Orphan...
Tenacia Bio Licenses Ztalmy to Golden Age Health – Bain-Backed CNS Specialist Partners on Rare Epilepsy Drug in China
Tenacia Biopharmaceuticals (Shanghai) Co., Ltd., a Bain Capital-incubated CNS specialist, announced a licensing agreement with...
Hansoh Pharma Wins NMPA Approval for Two Category 1 Drugs – HS‑20152 and HS‑10587 Enter Clinical Trials in Rare Disease and Oncology
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that two Category 1 innovative drugs have...
Abbisko Therapeutics Wins FDA Orphan Drug Designation for ABSK061 – Oral FGFR2/3 Inhibitor Targets Achondroplasia in Pediatric Patients
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that ABSK061 received Orphan Drug Designation (ODD) from...
Sanofi’s Venglustat Wins FDA Breakthrough Therapy Designation – Oral Brain-Penetrant GCSi Targets Gaucher Disease Type 3 Neurological Symptoms
Sanofi (NASDAQ: SNY) announced that venglustat received Breakthrough Therapy Designation (BTD) from the U.S. Food...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
BeBetter Medicine’s Ifupinostat Wins NMPA Approval for PTCL Trial – First HDAC/PI3Kα Dual Inhibitor Enters First-Line Lymphoma Study
Guangzhou BeBetter Medicine Technology Co., Ltd (SHA: 688759) announced NMPA clearance to initiate a clinical...
Abbisko’s ABSK061 Wins FDA Rare Pediatric Disease Designation – FGFR2/3 Inhibitor Targets Achondroplasia
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that ABSK061, its self-developed highly selective small-molecule FGFR2/3...
FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder
The U.S. Food and Drug Administration (FDA) approved expanded use of GlaxoSmithKline’s (GSK, NYSE: GSK)...