Harbour BioMed Resubmits Biological License Application for Batoclimab in China
Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands,...
Rare / orphan disease drugs
Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version...
Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials
Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced...
AbbVie-Calico Partnership Advances with FDA Approval for Fosigotifator Trial in Rare Brain Disorder
The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by...
Wanbangde’s Huperzine A Earns Orphan Drug Status from FDA for Treating Neonatal Brain Injury
Wanbangde New Building Materials Co., Ltd (SHE: 002082), a company operating in China, has announced...
Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the...
RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has...
Novartis’ Fabhalta Shows Promise in Late-Stage C3 Glomerulopathy Trial
Novartis AG (NYSE: NVS), a leading Swiss pharmaceutical company, last week announced positive preliminary data...
Novartis’ Atrasentan Shows Significant Reduction in Proteinuria in IgA Nephropathy Trial
Novartis AG (NYSE: NVS), a Swiss pharmaceutical company, last week presented interim results for the...
Gilead’s Seladelpar Shows Interim Benefits in PBC-Related Itch Clinical Trial
Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety...
Novo Nordisk’s Mim8 for Haemophilia A Exceeds Endpoints in Late-Stage Trial
Denmark-based healthcare company Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial...
Wanbangde Pharmaceutical’s Huperzine A Earns FDA Rare Pediatric Disease Designation for HIE Treatment
China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced that its subsidiary, Wanbangde...
Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced...
HuidaGene’s MECP2 Duplication Syndrome Therapy Earns Positive EMA Opinion
HuidaGene (Shanghai) Biotechnology Co., Ltd, a biotech company based in China, has announced that it...
Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE)...
Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan...
Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical...
Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD)...
Sanofi’s Rilzabrutinib Meets Primary Endpoint in Phase III ITP Trial
French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib,...
Ipsen’s Somatuline Receives First Prescription in China for GEP-NETs Treatment
French biopharmaceutical company Ipsen (EPA: IPN; OTCMKTS: IPSEY) has announced that the first prescription of...