BioNTech and DualityBio's ADC Candidate BNT324/DB-1311 Gains FDA Fast-Track Status for Prostate Cancer

The status is based on preclinical data and data from an ongoing phase 1/2 study for BNT324/DB-1311; preliminary phase 1/2 clinical data showed anti-tu...

June 25, 2024 | Tuesday | News
Japan Approves Takeda's LIVTENCITY® for Post-Transplant CMV Infection

Takeda announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cy...

June 24, 2024 | Monday | News
AbbVie’s SKYRIZI® Gains FDA Approval for Moderate to Severe Ulcerative Colitis and Crohn's Disease Following Successful Phase 3 Trials

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely ac...

June 20, 2024 | Thursday | News
Milestone Scientific Receives Regulatory Approval to Launch CompuFlo® Epidural System in Brazil

Milestone Scientific , a leading developer of computerized drug delivery instruments that provide painless and precise injections, announces that it has ...

June 19, 2024 | Wednesday | News
Junshi Biosciences' Toripalimab Approved in China for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

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

June 18, 2024 | Tuesday | News
Danish MedTech Company °MEQU Secures FDA Clearance for Portable Blood and IV Fluid Warmer

Danish MedTech company, °MEQU announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of the °M Warmer System - a ...

June 10, 2024 | Monday | News
FDA Accepts Eisai and Biogen’s Application for Monthly Maintenance Dosing of Alzheimer's Drug LEQEMBI

Eisai Co.,  and Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Applicat...

June 10, 2024 | Monday | News
FDA Grants Emergency Use Authorization for Roche's Rapid PCR Test for SARS-CoV-2, Influenza A/B, and RSV

The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and different...

June 10, 2024 | Monday | News
Moderna's mRNA-3705 Selected by FDA for START Pilot Program

Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program ...

June 07, 2024 | Friday | News
Bio-Thera's Biosimilar Bevacizumab Avzivi® Receives Positive CHMP Opinion, Moves Closer to European Approval

Bio-Thera Solutions , a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars,  announced th...

June 05, 2024 | Wednesday | News
FDA Launches START Program to Accelerate Rare Disease Drug Development

START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological p...

June 03, 2024 | Monday | News
ASP Japan Secures Exclusive Sales Contract with PENTAX Medical for Innovative Endoscopy Solutions

ASP Japan LLC (hereinafter referred to as ASP Japan) was announced by HOYA Group PENTAX Europe GmbH ( hereinafter referred to as PENTAX Medical) and the ...

May 31, 2024 | Friday | News
Thermo Fisher Scientific Enhances Chromosomal Microarray Analysis Solutions to Align with IVDR Regulation

   These enhancements represent Thermo Fisher's steadfast commitment to ensuring the highest standards of safety and efficacy in cytogenetic t...

May 31, 2024 | Friday | News
European Commission Approves Opdivo® Combination Therapy for First-Line Treatment of Metastatic Urothelial Carcinoma

Bristol Myers Squibb  announced that the European Commission (EC) has approved Opdivo®(nivolumab) in combination with cisplatin and gemcitabine ...

May 30, 2024 | Thursday | News

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