SynaptixBio Backs FDA Priority Review Voucher Renewal as Critical Lifeline for Rare Disease Innovation

SynaptixBio, the only company licensed to commercialise a treatment for a rare, deadly disease, says the Priority Review Voucher scheme is a lifeline for...

December 22, 2025 | Monday | News
Daiichi Sankyo–AstraZeneca’s DATROWAY Clears EMA Validation, Advancing Toward First-Line Use in Metastatic TNBC

Based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s DATROWAY is the first and only medicine to significantly...

December 19, 2025 | Friday | News
Harbour BioMed And Bristol Myers Squibb Forge Global Multi-Specific Antibody Alliance

Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immuno...

December 18, 2025 | Thursday | News
Antengene Expands XPOVIO® Approval in Malaysia to Relapsed or Refractory DLBCL

Antengene Corporation Limited, a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing fir...

December 18, 2025 | Thursday | News
Norgine Secures Exclusive Rights to Vir Biotechnology’s Hepatitis Delta Combination Therapy

Agreement underscores Norgine's mission to bring innovative therapies to patients and builds on our heritage in hepatology and specialty pharmaceutical...

December 18, 2025 | Thursday | News
GE HealthCare to Deploy 300+ Advanced CT Scanners Across Indonesia Under Landmark SIHREN Program

300+ advanced CT scanners to be installed in public hospitals across 38 provinces by 2028, to support early diagnosis and treatment of non-communicab...

December 18, 2025 | Thursday | News
Vanda Targets Mid-2026 Approval With Imsidolimab BLA for Generalized Pustular Psoriasis

Vanda Pharmaceuticals Inc.  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ims...

December 16, 2025 | Tuesday | News
RedHill Biopharma Highlights Opaganib as Potential Add-On Therapy for Venetoclax-Resistant CLL

Resistance to venetoclax (Venclexta® and Venclyxto®, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CL...

December 16, 2025 | Tuesday | News
Vaxxas Gains Regulatory Green Light to Manufacture HD-MAP for Clinical Trials

Australian biotechnology pioneer Vaxxas Pty Ltd, has been granted a licence by the Therapeutic Goods Administration (TGA) to manufacture the Company&rsqu...

December 16, 2025 | Tuesday | News
J&J’s AKEEGA Wins FDA Approval After Cutting Progression Risk by More Than Half in BRCA2-Mutated mCSPC

Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (n...

December 15, 2025 | Monday | News
Savara Secures Key European Patent for MOLBREEVI as It Prepares Global Regulatory Filings

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...

December 12, 2025 | Friday | News
SOLVD Health Launches Studies To Validate GLP 1 Patient Stratification Diagnostic Platform

SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, announced the launch of two s...

December 10, 2025 | Wednesday | News
SS Innovations Submits 510(k) Application to FDA for SSi Mantra Surgical Robotic System

SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic...

December 09, 2025 | Tuesday | News
Resmed Receives FDA Clearance for Smart Comfort, the First AI-Enabled Tool for Personalized CPAP Therapy Settings

Resmed , the leading health technology company focused on sleep, breathing and care delivered in the home, announced it has received U.S. Food and Drug A...

December 09, 2025 | Tuesday | News

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
Processing...
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2026 Biopharma Boardroom. All Rights Reserved.

Show

Forgot your password?

Show

Show

Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in

Close