Shanghai Junshi Biosciences’ Toripalimab sNDA Accepted by NMPA for First-Line Treatment of Advanced Melanoma

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

August 13, 2024 | Tuesday | News
FDA Approves First Non-Injection Epinephrine Nasal Spray, Neffy, for Life-Threatening Allergic Reactions

U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those th...

August 12, 2024 | Monday | News
Thermo Fisher Scientific's SeCore™ CDx HLA A Sequencing System Receives FDA Clearance as Companion Diagnostic for Adaptimmune’s TECELRA® TCR Therapy

Thermo Fisher Scientific Inc., the world leader in serving science,  announced that its SeCore™ CDx HLA A Sequencing System has been granted 5...

August 07, 2024 | Wednesday | News
Agilent Receives FDA Approval for MAGE-A4 IHC 1F9 pharmDx as a Diagnostic Tool for Use with Newly Approved TCR T-Cell Therapy

Agilent that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovia...

August 05, 2024 | Monday | News
FDA Grants Accelerated Approval for TECELRA in Advanced Synovial Sarcoma Treatment

Approved for advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy TECELRA is the first new treatment ...

August 02, 2024 | Friday | News
FDA Grants Priority Review to Vertex's Suzetrigine, Targeting January 2025 for Action Date

FDA grants priority review and assigns a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025 – – Suzetrigine...

July 30, 2024 | Tuesday | News
MSD Announces Positive CHMP Opinion for KEYTRUDA® and Padcev® Combo in Advanced Urothelial Carcinoma

MSD (NYSE: MRK), known as Merck & Co., Inc. in the United States and Canada, today announced that the European Medicines Agency’s Committee for...

July 29, 2024 | Monday | News
European Commission Approves AbbVie’s SKYRIZI® for Treatment of Moderately to Severely Active Ulcerative Colitis

AbbVie announced that the European Commission has approved SKYRIZI® (risankizumab) for the treatment of adult patients with moderately to severely ac...

July 29, 2024 | Monday | News
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

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