Approval based primarily on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved...
Mesoblast's Chief Executive, Silviu Itescu, expressed satisfaction with the FDA's decision: “We are very pleased to have now been granted both Orphan...
Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a distinguished player in the clinical-stage biopharmaceutical arena, has achieved a significant milestone wit...
Viz.ai, a pioneering force in AI-driven disease detection and intelligent care coordination, has attained a significant milestone with the receipt ...
NICE Final Draft Guidance recommends providing National Health System (NHS) patients with a phakic lens access to the only sustained-release treatment last...
The ODD granted to RZ-001 in HCC may allow it to receive 7 years of marketing exclusivity upon product approval, exemption from user fee and tax credits. T...
Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company ded...
“Myositis, believed to be driven by B cells, is a severe and potentially fatal autoimmune disease for which no curative therapy exists. Current treat...
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulti...
— First medicine approved under new “1+” mechanism by HKSAR Government, providing an important treatment option to patients in Hong Kong&...
Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East...
Celltrion USA announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar...
Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo&nbs...
Thermo Fisher Scientific, the world leader in the service of science, has received Good Manufacturing Practice (GMP) approval from the Italian Medicines Ag...
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