Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received...
Rare / orphan disease drugs
Novo Nordisk and Evotec Launch LAB eN² to Accelerate Drug Discovery for Rare Diseases
Global healthcare company Novo Nordisk (NYSE: NVO) and drug discovery alliance Evotec (NASDAQ: EVO) have...
Sanofi’s Altuviiio Receives Marketing Approval from Japan’s MHLW for Hemophilia A Treatment
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from...
Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its...
EU Chamber of Commerce in China Releases Position Paper, Addresses Pharma and Healthcare
The EU Chamber of Commerce in China has released its bi-annual “European Business in China...
Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
US-based Organon (NYSE: OGN) has announced that it has received market approval from the National...
China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
The National Health Commission (NHC) of China has released an updated national list of rare...
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...
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...