NOVIO's INO-3107 Achieves EMA Certification for Recurrent Respiratory Papillomatosis Treatment

NOVIO a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related disease...

July 26, 2024 | Friday | News
Varian Receives FDA Clearance for Enhanced Ethos 2.0 Therapy System, Streamlining Adaptive Radiotherapy

Varian, a Siemens Healthineers company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new functionality to its ...

July 23, 2024 | Tuesday | News
Johnson & Johnson Seeks FDA Approval for SPRAVATO® Nasal Spray as Monotherapy for Treatment-Resistant Depression

Johnson & Johnson  announced  the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) s...

July 23, 2024 | Tuesday | News
GC Cell and Lukas Biomedical Forge Strategic International Partnership

 GC Cell Corporation (hereinafter referred to as "GC Cell"; 144510:KOSDAQ) and Lukas Biomedical Co., Ltd. (hereinafter referred to as "Lukas," TWSE ...

July 22, 2024 | Monday | News
Innovent Biologics Announces Phase 3 Success for Mazdutide in Treating Type 2 Diabetes

Innovent Biologics, a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of on...

July 22, 2024 | Monday | News
Understanding the Biosecure Act: Implications for the Pharmaceutical Industry

  The Biosecure Act is a significant legislative proposal aimed at reshaping the pharmaceutical supply chain landscape, particularly concerning the s...

July 21, 2024 | Sunday | Reports
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

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