Fosun Pharma Secures NMPA Approval for Fumaining in Pediatric Langerhans Cell Histiocytosis – Expands MEK Inhibitor Franchise
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196; HKG: 2196) announced that China’s National Medical Products...
Rare / orphan disease drugs
Pfizer Secures FDA Approval for Marstacimab Expanded Indication in Hemophilia A and B Across Pediatric and Adult Populations
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has...
Huahai Pharmaceutical Receives NMPA Approval for Dual-Target IPF Therapy HB0056, Adding to Global Clinical Trial Authorizations
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced it has received clinical trial approval from...
Sanofi’s Venglustat Receives FDA Priority Review and Breakthrough Therapy Designation for Type 3 Gaucher Disease
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted priority...
AbbVie Secures FDA Approval for DECNUPAZ in Blastic Plasmacytoid Dendritic Cell Neoplasm – First CD123-Targeting ADC Addresses Ultra-Rare Hematologic Malignancy
AbbVie Inc. (NYSE: ABBV) announced on May 27, 2026, that the U.S. Food and Drug...
Changchun High & New Technology Industries Subsidiary Secures NMPA Approval for GenSci144, Novel Oral PKU Treatment Targeting SLC6A19 Transporter
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun...
Boehringer Ingelheim’s Ofev Receives CHMP Endorsement for Idiopathic and Progressive Pulmonary Fibrosis
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a...
Lundbeck’s Asedebart Receives Japanese Orphan Drug Designation for Congenital Adrenal Hyperplasia and Cushing’s Disease
Lundbeck (OTCMKTS: HLUBF) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted...
Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement
Pfizer Inc. (NYSE: PFE) announced it has received European Commission (EC) approval for an indication...
Kanghong Pharma’s Gene Therapy KHN921 Receives FDA Approval for Hypertrophic Cardiomyopathy Trial – AAV9 Vector Targets MYBPC3 Mutations with Potential One-Time Treatment
Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced that its subsidiary Chengdu Origen Biotechnology...
Hybio Pharmaceutical Expands Torrent Pharma Partnership with Lanreotide Acetate for U.S. Market
Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced an expanded strategic partnership with Torrent Pharmaceuticals Inc.,...
Keymed Biosciences Secures NMPA Breakthrough Therapy Designation for CM336 in AL Amyloidosis
Keymed Biosciences Inc. (HKG: 2162) announced that its BCMA×CD3 T cell engager (TCE), CM336 (OM336),...
HutchMed’s Sovleplenib Granted NMPA Priority Review for Warm Antibody Autoimmune Hemolytic Anemia
HutchMed (China) Limited (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Insilico Medicine Secures Chinese Clinical Clearance for AI-Discovered Rentosertib Inhalation in Pulmonary Fibrosis
Insilico Medicine (HKG: 3696), a generative artificial intelligence (AI)-driven biotechnology company, announced it has received...
Santo Therapeutics Secures Dual FDA Designations for ST002 Gene Therapy in NF2-Related Schwannomatosis – Advancing In Vivo Lentiviral Platform
Santo Therapeutics, a Hangzhou-based in vivo gene therapy developer, announced it has received both Orphan...
Johnson & Johnson’s Imaavy (nipocalimab) Receives FDA Priority Review for Warm Autoimmune Hemolytic Anemia – Expanding FcRn Blocker Franchise
Johnson & Johnson (J&J, NYSE: JNJ) announced that its supplemental Biologics License Application (sBLA) for...
Prothena’s Coramitug Receives FDA Fast Track Designation for ATTR-CM – Advancing Novo Nordisk’s $1.2B Amyloidosis Pipeline
Prothena Corporation plc (NASDAQ: PRTA) announced that the U.S. Food and Drug Administration (FDA) has...
Novartis Wins CHMP Positive Opinion for Itvisma (Intrathecal Onasemnogene Abeparvovec) in 5q Spinal Muscular Atrophy Across All Ages in EU
Novartis AG (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP)...
Boehringer Ingelheim Launches Pulmonary Fibrosis Care Initiative in China with CNR News, Tencent Medipedia, and Patient Groups to Combat Underdiagnosed Fatal Lung Disease
Boehringer Ingelheim, the German pharmaceutical giant, officially launched the Pulmonary Fibrosis Care Initiative late last...
Insilico Medicine Advances AI-Designed PRMT5 Inhibitor ISM0387 for Glioblastoma with Sub-12-Month Discovery Timeline
Insilico Medicine (HKG: 3696), a China-based artificial intelligence (AI) drug discovery platform, announced the selection...