Daiichi Sankyo and AstraZeneca Secure EMA Validation for ENHERTU Combination in First-Line HER2-Positive Metastatic Breast Cancer

Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significant...

January 20, 2026 | Tuesday | News
Apiject to Open 30,000-Square-Foot Pharmaceutical Manufacturing Facility in North Carolina

30,000-Square-Foot Facility Will Advance America's Priority to Reshore Essential Drug Manufacturing Apiject Holdings, Inc. announced the signing of a le...

January 19, 2026 | Monday | News
Atossa Therapeutics Secures FDA Orphan Drug Designation for (Z)-Endoxifen in Duchenne Muscular Dystrophy

Designation further supports (Z)-Endoxifen program into rare pediatric neuromuscular disease along with previously received Rare Pedi...

January 19, 2026 | Monday | News
China Approves Sanofi’s Myqorzo and Redemplo for Cardiovascular and Rare Metabolic Diseases

Approval of Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronemia syndrome Underscores Sanofi’s long-ter...

January 16, 2026 | Friday | News
MARS Bioimaging Raises $15M Series A to Scale 3D Colour Spectral CT Imaging Globally

Investment to accelerate commercial adoption of MARS Bioimaging’s spectral CT scanners for 3D colour X-ray imaging   MARS Bioimaging, a New Z...

January 16, 2026 | Friday | News
Oxford Nanopore’s GridION™ Dx Receives CE and UKCA Marking in UK and Europe

Oxford Nanopore has reached a major regulatory milestone with the registration of its first In Vitro Diagnostic (“IVD”) device in the UK an...

January 13, 2026 | Tuesday | Regulatory
Tensive Reports Positive Pivotal Trial Results for REGENERA™ in Lumpectomy Patients

Clinical data from pivotal trial in patients undergoing lumpectomy confirm strong safety profile and growing performance benefits Primary safety endp...

January 09, 2026 | Friday | News
HealthBiome Secures Dual U.S. FDA and Korean MFDS Approvals for Akkermansia Postbiotic with Muscle Health Claim

Akkermansia muciniphila postbiotic receives both U.S. FDA dietary supplement clearance and Korean functional ingredient approval with muscle health ...

January 08, 2026 | Thursday | News
Acesion Pharma Enrols First Patients in Phase 2 Trial of Novel Oral AF Therapy

AP31969 is a novel, first-in-class, oral SK ion channel inhibitor intended for rhythm control of atrial fibrillation and has recently completed Phase 1 i...

January 07, 2026 | Wednesday | News
Eisai and Biogen Secure NMPA Acceptance for Subcutaneous LEQEMBI in China

If approved, lecanemab may become the first and only anti-amyloid treatment in China to offer an at-home injection from the initiation of treatment for...

January 07, 2026 | Wednesday | News
WuXi Biologics Achieves ISO 20400 Sustainable Procurement Certification, Strengthening Global Supply Chain Resilience

WuXi Biologics (2269.HK) announced it has achieved ISO 20400 Sustainable Procurement certification, an internationally recognized standard that integrate...

January 06, 2026 | Tuesday | News
Axsome Biotherapeutics Stock Surges As FDA Grants Priority Review

Axsome Biotherapeutics announced that the US regulator has granted Priority Review to its investigational therapy for agitation associated with Alzheimer...

January 05, 2026 | Monday | News
Valneva Regains Full Rights to Single-Shot Chikungunya Vaccine, Ends Licensing Deal with Serum Institute of India

Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Grou...

January 02, 2026 | Friday | News
Zevra Therapeutics Signs Exclusive Expanded Access Distribution Deal With Uniphar for MIPLYFFA

Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare ...

December 31, 2025 | Wednesday | News

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