Shanghai Junshi Biosciences' sNDA for Toripalimab and Bevacizumab Combo for Advanced Liver Cancer Accepted by NMPA

  Shanghai Junshi Biosciences Co., a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercializati...

July 19, 2024 | Friday | News
Taiwan's Senhwa Biosciences Submits IND to US FDA for Phase I/II Study of Silmitasertib in Pediatric Cancer Treatment

  Senhwa Biosciences, Inc. (TPEx: 6492), announced IND Submission to US FDA for the Phase I/II study of Silmitasertib (CX-4945) in combination with c...

July 12, 2024 | Friday | News
Eisai and Biogen Announce Approval of Alzheimer’s Treatment LEQEMBI® in Israel

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher...

July 12, 2024 | Friday | News
AHB-137 Receives Breakthrough Therapy Designation from NMPA, Paving the Way for Faster Access to Chronic Hepatitis B Treatment

AHB-137 gains Breakthrough Therapy Designation (BTD) from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety and efficacy. BTD...

July 11, 2024 | Thursday | News
BioArctic AB’s Partner Eisai Announces Approval of Leqembi® (樂意保®) for Alzheimer’s Disease Treatment in Hong Kong

BioArctic AB  is pleased to announce that its partner, Eisai, has received approval from the Department of Health in Hong Kong for Leqembi® (bra...

July 11, 2024 | Thursday | News
Roche Receives CE Mark for Accu-Chek® SmartGuide CGM Solution, Empowering Diabetes Management in Europe

Roche  announced  that it has received the CE Mark for its Accu-Chek® SmartGuide continuous glucose monitoring (CGM) solution. This signifi...

July 09, 2024 | Tuesday | News
HUTCHMED's New aDrug Application for Tazemetostat in Relapsed or Refractory Follicular Lymphoma Granted Priority Review by China NMPA

HUTCHMED (China) Limited (“HUTCHMED”)  announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of...

July 04, 2024 | Thursday | News
CSL Behring Achieves European Milestone with First Real-World Treatments of Hemophilia B Using HEMGENIX® Gene Therapy

Global biotechnology leader CSL Behring  announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dez...

July 04, 2024 | Thursday | News
Vertex Pharmaceuticals' Vanza Triple Granted Priority Review by FDA with Target Action Date of January 2, 2025

Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 – - EU Marketing Authorizat...

July 03, 2024 | Wednesday | News
FDA Approves Eli Lilly's Kisunla™ for Early Symptomatic Alzheimer's Disease

Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk...

July 03, 2024 | Wednesday | News
Samsung Bioepis Receives FDA Approval for PYZCHIVA® as Biosimilar to Stelara for Multiple Inflammatory Conditions

Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA&re...

July 01, 2024 | Monday | News
SCG Cell Therapy Receives FDA Approval for IND to Initiate HPV TCR T Cell Therapy Trials in Singapore

SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today anno...

July 01, 2024 | Monday | News
Cepheid Secures FDA Authorization and CLIA Waiver for Revolutionary Xpert® HCV Test

Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for ...

June 28, 2024 | Friday | News
Regulatory Review Begins for Bavarian Nordic's Single-Dose Chikungunya Vaccine in EU and U.S.

Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individua...

June 26, 2024 | Wednesday | News

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