Regen BioPharma Advances HemaXellerate Toward Phase 1 Trials Following FDA Clearance

Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company&...

August 18, 2025 | Monday | News
Invivyd Secures FDA Alignment on Single Phase 2/3 Trial Pathway for VYD2311 COVID-19 Prevention BLA

Alignment follows Type C meeting for VYD2311 as previously disclosed BLA pathway for VYD2311 to be supported by a single, Phase 2/3 randomized, doubl...

August 15, 2025 | Friday | News
Simpson Interventions Treats First Patients in Pivotal Trial of Acolyte™ Image-Guided Catheter for Complex Coronary Blockages

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, announced that its groundbrea...

August 15, 2025 | Friday | News
Insmed Secures FDA Approval for BRINSUPRI™, the First-Ever Treatment for Non-Cystic Fibrosis Bronchiectasis

Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung D...

August 14, 2025 | Thursday | News
Bayer and Kumquat Biosciences Partner to Develop First-in-Class KRAS G12D Inhibitor for Hard-to-Treat Cancers

Collaboration focuses on developing a KRAS G12D inhibitor, complementing Bayer’s precision oncology development portfolio in the areas of pancr...

August 13, 2025 | Wednesday | News
Boehringer Ingelheim Secures FDA Accelerated Approval for HERNEXEOS® (Zongertinib) in HER2-Mutant Advanced NSCLC

HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 75% (N=71), as demonstrated in the Beamion-LUNG 1 clinical trial ...

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
Axplora Announces €6.5 Million Expansion at Vizag Site Following Successful USFDA Inspections in India

Axplora, a global leader in API small molecule manufacturing, today announced a significant investment at its Vizag site in India to expand production ca...

August 06, 2025 | Wednesday | 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
FDA Approves Apellis’ EMPAVELI® as First-Ever Treatment for Rare Kidney Diseases C3G and IC-MPGN

Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first tre...

July 29, 2025 | Tuesday | 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

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