Caliway Biopharmaceuticals’ CBL-514 Achieves Milestones in Dercum’s Disease Trial
Taiwan-based Caliway Biopharmaceuticals, a specialist in medical aesthetics and inflammatory medicine, has announced that its...
Rare / orphan disease drugs
AstraZeneca’s Fasenra Shows Non-Inferior Efficacy to Nucala in EGPA: Phase III Results
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has unveiled the results of a Phase III...
NMPA Pilots Priority Review for Rare Disease Formula Foods, Aims to Reduce Approval Time
The National Medical Products Administration (NMPA) has initiated a pilot program to implement “Priority review...
Grand Pharmaceutical Receives NMPA Approval for Generic Carbaglu for Hyperammonemia Treatment
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval...
CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy...
AstraZeneca’s Ultomiris Faces FDA Rejection for NMOSD Indication Extension
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has received a rejection from the US Food...
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab,...
Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO)...
Amgen and Horizon Therapeutics Reach Agreement with FTC to Proceed with Acquisition
Amgen (NASDAQ: AMGN) and Horizon Therapeutics (NASDAQ: HZNP) have announced a consent order agreement with...
AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an...
Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC)...
Cordavis Launches First Biosimilar: Novartis’ Hyrimoz to Compete with Humira
Swiss pharmaceutical giant Novartis (NYSE: NVS) unit Sandoz’s biosimilar product, Hyrimoz (adalimumab), which references AbbVie’s...
Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS
Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug...
Humanwell Healthcare Initiates Phase IIa Clinical Study for IPF Drug HW021199
China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced the commencement of a Phase...
GC Biopharma Presents Data Showing Higher Thrombotic Risk with Roche’s Hemlibra
South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia...
Immunofoco’s IMC008 Earns Orphan Drug Designation for Gastric Cancer from FDA
Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD)...
Novartis Acquires Chinook Therapeutics for $3.2 Billion, Eyes Kidney Disease Market
Switzerland-based pharmaceutical major Novartis (NYSE: NVS) has successfully completed the scheduled purchase of US-based kidney...
Beijing’s Gene Cradle Secures Pre-Series B+ Funding Led by Cash Capital
Gene Cradle, a Beijing-based gene therapy specialist, has reportedly secured tens of millions of renminbi...
ABM Therapeutics’ ABM-1310 Earns Orphan Drug Designation for BRAF V600 Mutant Glioblastoma
Shanghai-based ABM Therapeutics Inc. has announced that it has received Orphan Drug Designation (ODD) from...
CDE Issues Guiding Principles for Natural History Research in Rare Disease Drug Development
The Center for Drug Evaluation (CDE) has released the “Guiding Principles for Natural History Research...