Valneva Faces US FDA Suspension of IXCHIQ® Vaccine Licence After New Safety Reports

Valneva SE , a specialty vaccine company, announced that the United States Food and Drug Administration (FDA) has suspended the license for IXCHIQ&r...

August 25, 2025 | Monday | News
Innovent Biologics Receives FDA Clearance to Launch First Global Phase 3 Trial of IBI363 in IO-Resistant Lung Cancer

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company committed to developing, manufacturing and commercializing h...

August 25, 2025 | Monday | News
Agilent MMR IHC Panel pharmDx Wins FDA Approval as Companion Diagnostic for Colorectal Cancer

-Agilent Technologies Inc. announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for ...

August 21, 2025 | Thursday | News
Qihan Biotech Receives FDA Clearance to Begin U.S. Trial of Universal CAR-T Therapy for Refractory Lupus

Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to...

August 19, 2025 | Tuesday | News
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

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