MUVON Therapeutics Reports Positive Topline Results From Phase 2 SUISSE-MPC2 Trial of MPC-Based Therapy in Female Stress Urinary Incontinence

MUVON Therapeutics AG, a clinical-stage biotechnology company, reports positive topline results from the Phase 2 clinical trial SUISSE-MPC2 (NCT0553...

December 04, 2025 | Thursday | News
VNA-318 Demonstrates Strong Target Engagement and Safety in First-in-Human Trial

VNA-318, an oral brain-penetrant small molecule therapeutic modulates a novel target to reduce inflammation and improve mitochondrial function First-i...

December 03, 2025 | Wednesday | News
Ensoma Launches First-In-Human Study of EN-374 Offering New Hope for People With X-Linked CGD

First ever clinical evaluation of an in vivo HSC-directed gene insertion therapy aims to restore immune function for people living with X-linked chroni...

December 02, 2025 | Tuesday | News
InnoCare Pharma Doses First Patient in Global Phase II Trial of Soficitinib for Prurigo Nodularis

InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced tha...

December 01, 2025 | Monday | News
SK Biopharmaceuticals Deepens Radiopharma Strategy With Exclusive License to WT-7695 From WARF

  New addition strengthens SK Biopharmaceuticals' radiopharmaceutical therapy portfolio and reinforces its R&D capabilities through global partne...

November 28, 2025 | Friday | News
BeOne Medicines’ Sonrotoclax Granted FDA Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has a...

November 27, 2025 | Thursday | News
AstraZeneca’s IMFINZI Plus FLOT Receives US Approval as First Neoadjuvant Immunotherapy for Early Gastric and GEJ Cancers

AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxe...

November 27, 2025 | Thursday | News
GE HealthCare Receives FDA Authorization for Pristina Recon DL, a Breakthrough in AI-Enhanced 3D Mammography

GE HealthCare (Nasdaq: GEHC) announced that it has received FDA Premarket Authorization for Pristina Recon DL, an advanced 3D mammography image reconstru...

November 27, 2025 | Thursday | News
USPTO Grants Notice of Allowance for Enveric’s EVM401 Neuroplastogen Patent

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-m...

November 27, 2025 | Thursday | News
Sarepta Receives FDA Approval to Initiate Cohort 8 Evaluating Sirolimus With ELEVIDYS in Non-Ambulant Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to be...

November 26, 2025 | Wednesday | News
Aidoc Sets New Benchmark in Clinical AI With Foundation Model FDA Submission and 100M Real-World Cases

Aidoc, the global leader in clinical AI with the most FDA-cleared CAD solutions,  announced a major milestone: the completion of its pivotal study a...

November 26, 2025 | Wednesday | News
MDA Applauds FDA Approval of Itvisma, the First Gene Replacement Therapy for a Broad SMA Population

The Muscular Dystrophy Association (MDA)  called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve), ...

November 26, 2025 | Wednesday | News
EMD Serono Advances First Potential Oral gMG Therapy with FDA Fast Track Designation

  Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, g...

November 25, 2025 | Tuesday | News
GE HealthCare Advances CT Innovation with 510(k) Submission for Photonova™ Spectra Photon-Counting System

GE HealthCare announced the submission of a 510(k) to the U.S. FDA seeking clearance for Photonova™ Spectra, its new photon-counting computed ...

November 25, 2025 | Tuesday | Regulatory

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