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...
Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to intravenous (IV) infusion and is preferred by cancer patien...
RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently dev...
Approval by the Medicines and Healthcare products Regulatory Agency (MHRA) of AGAMREE® in the United Kingdom follows marketing authorization for this...
— NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 — — NDA is supported b...
-Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the Saudi Food and Drug Authority (SFDA) granted Marketing Authorization for CASGE...
Pfizer Inc. announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in c...
© 2025 Biopharma Boardroom. All Rights Reserved.
