Neurona Therapeutics Treats First Non-MTS Subject in Phase 1/2 Trial of NRTX-1001 for Drug-Resistant Temporal Lobe Epilepsy

  - First subject received unilateral administration of NRTX-1001 in a new non-MTS cohort; no significant surgical complications or adverse events re...

October 09, 2025 | Thursday | News
Avobis Bio Earns FDA RMAT Designation for AVB-114 in Crohn’s Perianal Fistulas

Avobis Bio LLC, a clinical-stage company developing implantable cell therapies, announced  that the U.S. Food and Drug Administration ("FDA") has gr...

October 06, 2025 | Monday | News
Sitryx Therapeutics Receives FDA Clearance to Advance SYX-5219 Into Phase 1b Trial for Atopic Dermatitis

SYX-5219 is a first-in-class oral PKM2 modulator designed to drive sustained disease remission across a range of autoimmune diseases Phase 1b trial to...

October 03, 2025 | Friday | News
BMS’s BMS-986446 Receives FDA Fast Track Designation for Early Alzheimer’s Therapy

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease Fas...

October 02, 2025 | Thursday | News
Polyrizon Submits FDA Pre-Submission Package for PL-14 Allergy Blocker Nasal Spray

Polyrizon Ltd., a biotechnology company focusing on the development of intranasal products announced the submission of its full pre-submission (Pre-Sub) ...

September 22, 2025 | Monday | News
Lupin Secures U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension with 180-Day CGT Exclusivity

Global pharma major Lupin Limited  announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Ab...

September 12, 2025 | Friday | News
Greenwich LifeSciences Secures FDA Fast Track Designation for GLSI-100 in Breast Cancer

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-0...

September 11, 2025 | Thursday | News
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

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