Sanofi’s Wayrilz Wins FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia

Novel treatment targets BTK through multi-immune modulation to help address root causes of ITP Approval based on LUNA 3 phase 3 study that demonstrate...

September 01, 2025 | Monday | News
Piramal Pharma Solutions and George Medicines Achieve FDA Approval for WIDAPLIK, the First Triple Combination Hypertension Therapy

Piramal Pharma Solutions extended its robust CDMO capabilities to George Medicines to develop WIDAPLIK. WIDAPLIK is the first and only FDA-approved tr...

August 29, 2025 | Friday | News
United Therapeutics Exercises Option with MannKind to Develop Second Inhaled Therapy

MannKind Corporation announced that United Therapeutics Corporation  has exercised its option—granted under the companies’ 2018 lic...

August 28, 2025 | Thursday | News
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 IX...

August 26, 2025 | Tuesday | 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

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