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
Sanofi Completes Acquisition of Blueprint Medicines, Strengthening Rare Immunology Portfolio

Sanofi announces the completion of its acquisition of Blueprint Medicines Corporation (Blueprint), adding to its portfolio a commercialized medicine, a p...

July 21, 2025 | Monday | News
FDA Halts Sarepta’s Gene Therapy Trials After Deaths; Platform Designation Revoked Amid Safety Concerns

The U.S. Food and Drug Administration announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular ...

July 21, 2025 | Monday | Regulatory
Johnson & Johnson’s TAR-200 Receives FDA Priority Review for BCG-Unresponsive Bladder Cancer

New Drug Application supported by results from the Phase 2b SunRISe-1 study Johnson & Johnson announced that the U.S. Food and Drug Administration (...

July 18, 2025 | Friday | News
AAVantgarde Receives FDA Clearance for AAVB-039 to Treat Stargardt Disease

AAVantgarde Bio (AAVantgarde), a clinical-stage biotechnology company developing next-generation gene therapies for inherited retinal diseases,  ann...

July 16, 2025 | Wednesday | News
Biocon Biologics Secures FDA Approval for Kirsty™, the First Interchangeable Biosimilar to NovoLog® in the U.S.

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. announced that the U.S. Food and Drug Administrat...

July 16, 2025 | Wednesday | News
Ultragenyx Receives Complete Response Letter from FDA for UX111 Gene Therapy for Sanfilippo Syndrome Type A

Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics L...

July 14, 2025 | Monday | News
Trethera’s TRE-515 Receives FDA Fast Track Designation for Advanced Prostate Cancer Treatment

Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune d...

July 11, 2025 | Friday | News
Zhimeng Biopharma Receives CDE Approval to Advance CB03-154 into Phase 2/3 Trials for ALS in China

Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma"), a clinical-stage biopharmaceutical company dedicated to innovative drug development for liver and...

July 10, 2025 | Thursday | News
SimBioSys Secures Third FDA Clearance for TumorSight™ Viz to Advance Precision in Breast Cancer Surgery

SimBioSys®, a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment, today announced its third FDA 510(k) c...

July 10, 2025 | Thursday | News
Purespring Therapeutics Receives FDA Clearance to Initiate Clinical Trials for IgA Nephropathy Gene Therapy

Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, announces that the U.S. Food and Drug A...

July 10, 2025 | Thursday | News
Longeveron Receives FDA Clearance to Begin Phase 2 Trial of Stem Cell Therapy for Pediatric Dilated Cardiomyopathy

 Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and...

July 09, 2025 | Wednesday | News

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