IASO Biotherapeutics Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
China-based IASO Biotherapeutics has received clinical trial approval from the National Medical Products Administration (NMPA)...
Rare / orphan disease drugs
Boan Biotech Secures FDA Orphan Drug Designations for Two Claudin18.2 Targeting Candidates
Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan...
Lingyi Biotechnology’s Gene Therapy Candidate LY-M001 Gets FDA Green Light for Gaucher’s Disease
Lingyi Biotechnology Co., Ltd, a China-based gene therapy developer, has secured clinical trial approval from...
Sanofi Acquires Rare Disease Candidate INBRX-101 in $1.7 Billion Deal
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced the acquisition of INBRX-101, a promising candidate...
Visirna Therapeutics Completes Enrollment in Phase III Study for FCS Drug VSA001
Visirna Therapeutics, a Shanghai-based biopharmaceutical company, has announced the completion of patient enrollment in a...
HuidaGene Therapeutics’ CRISPR Therapy Earns Orphan Drug Status for Duchenne Muscular Dystrophy
China-based biotechnology company HuidaGene Therapeutics has announced that it has received Orphan Drug Designation (ODD)...
Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study...
Yifan Pharmaceutical Wins Nod for Generic Diazoxide Oral Suspension in China
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that it has...
Drug Farm’s DF-003 Earns FDA Rare Pediatric Disease Designation for ROSAH Syndrome
Sino-US biotech company Drug Farm has announced that it has received Rare Pediatric Disease Designation...
Amgen Licenses XeriJect Technology from Xeris Biopharma for Subcutaneous Tepezza Development
Amgen (NASDAQ: AMGN) has entered into a licensing agreement with Xeris Biopharma (NASDAQ: XERS) for...
Abbisko Therapeutics’ Pimicotinib Earns Orphan Drug Designation from EMA for TGCT Treatment
Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has...
Shanghai BDgene Technology’s Thalassemia Gene Therapy BD211 Clears NMPA for Clinical Trials
Shanghai BDgene Technology Co., Ltd, a specialist in gene therapy, has received clinical trial approval...
Belief BioMed Group Initiates Clinical Study for Hemophilia A Gene Therapy BBM-H803 in China
Belief BioMed Group, a Shanghai-based gene therapy specialist, has announced the first subject dosing in...
BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers...
Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate...
Janssen Acquires Rights to Gene Therapy Botaretigene Sparoparvovec from MeiraGTx for XLRP Treatment
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), announced last week its...
AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food...
Simcere Affiliate Shanghai Simnova Biotech Gets China Nod for CAR-T Therapy SNC109
Shanghai Simnova Biotech Co., Ltd, known as Simnova outside of China and an affiliate of...
HuidaGene Secures Rare Pediatric Disease Designation for CRISPR Therapy HG302 Targeting DMD
HuidaGene Therapeutics, based in China, has announced that it has received Rare Pediatric Disease Designation...
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...