Junshi Biosciences’ sNDA for Toripalimab Plus Disitamab Vedotin in HER2-Expressing Urothelial Carcinoma Accepted by China’s NMPA

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to th...

August 11, 2025 | Monday | News
Nyxoah Secures FDA Approval for Genio System to Treat Moderate to Severe Obstructive Sleep Apnea

Nyxoah SA , a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, ann...

August 11, 2025 | Monday | News
Avobis Bio Seeks FDA RMAT Designation for AVB-114 Following Positive Phase II Results

Analysis leads to FDA RMAT submission and late-breaking abstract for implantable cell therapy - Avobis Bio LLC, a clinical stage company developing impl...

August 08, 2025 | Friday | News
Bristol Myers Squibb’s Breyanzi Granted FDA Priority Review for Relapsed or Refractory Marginal Zone Lymphoma

Breyanzi has the potential to be the first and only CAR T cell therapy approved for MZL, addressing a high unmet need Application based on results fro...

August 05, 2025 | Tuesday | News
Taiwan’s Anbogen Therapeutics Receives FDA IND Approval to Initiate Global Phase 1/2 Trial for ABT-301 in Metastatic Colorectal Cancer

Anbogen Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, ...

August 04, 2025 | Monday | News
IntraBio’s AQNEURSA® Receives Positive CHMP Opinion for Niemann-Pick Type C, Paving Way for European Approval

AQNEURSA® could offer a new frontline treatment for NPC patients in Europe CHMP recommendation based on Phase III pivotal trial data and extensi...

July 31, 2025 | Thursday | News
CORXEL Submits NDA for LENZ Therapeutics’ LNZ100 in China, Marking First Global Regulatory Filing for Aceclidine-Based Eye Drop for Presbyopia

LENZ Therapeutics, Inc. a pre-commercial stage biopharmaceutical company focused on the development and commercialization of the first and only aceclidin...

July 29, 2025 | Tuesday | News
Sanofi Secures EU Approval for Sarclisa + VRd in Transplant-Eligible Newly Diagnosed Multiple Myeloma

Approval based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and pro...

July 28, 2025 | Monday | News
GH Research Reports 73% Remission in TRD with GH001; Global Pivotal Trial Set for 2026

Engagement with FDA on GH001 IND complete response ongoing The fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months...

July 25, 2025 | Friday | News
SpringWorks Wins EU Nod for EZMEKLY® in NF1-Related Tumours

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced  that the European Commission (EC) granted conditi...

July 21, 2025 | Monday | News
Johnson & Johnson’s TAR-200 Receives FDA Priority Review for BCG-Unresponsive Bladder Cancer

New Drug Application supported by results from the Phase 2b SunRISe-1 study Johnson & Johnson announced that the U.S. Food and Drug Administration (...

July 18, 2025 | Friday | News
Ultragenyx Receives Complete Response Letter from FDA for UX111 Gene Therapy for Sanfilippo Syndrome Type A

Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics L...

July 14, 2025 | Monday | News
CARsgen Secures Final EPO Win for GPC3 CAR-T Patent After Appeal Withdrawal

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces a favorable outco...

July 14, 2025 | Monday | News
Trethera’s TRE-515 Receives FDA Fast Track Designation for Advanced Prostate Cancer Treatment

Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune d...

July 11, 2025 | Friday | News

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