Samsung Bioepis to Assume Full Commercial Control of BYOOVIZ in Europe by January 2026

  Samsung Bioepis will assume full commercial responsibility for BYOOVIZ®(ranibizumab) upon full transition of Biogen’s commercializa...

October 30, 2025 | Thursday | News
Curia Completes $4 Million Upgrade of Valladolid API Suites to Meet Enhanced EU GMP Annex 1 Standards

Curia Global, Inc. (Curia), a leading global research, development and manufacturing organization, today announced the completion of a $4 million investm...

October 28, 2025 | Tuesday | Regulatory
Naobios and Tokyo Metropolitan Institute of Medical Science Partner to Develop Next-Generation Mpox Vaccine

Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of virus-ba...

October 24, 2025 | Friday | News
Salvat Secures FDA Approval for Clotic®, the First Targeted Therapy for Otomycosis with Orphan Drug Designation

SALVAT receives FDA approval for Clotic®, an innovative treatment for otomycosis with Orphan Drug Designation     Th...

October 22, 2025 | Wednesday | News
Genentech’s Gazyva® Receives FDA Approval for the Treatment of Lupus Nephritis in Adults

 The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus n...

October 21, 2025 | Tuesday | News
Agios Pharmaceuticals Receives CHMP Positive Opinion for PYRUKYND® in Treating Alpha- and Beta-Thalassemia

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rar...

October 20, 2025 | Monday | News
Kezar Life Sciences Initiates Strategic Review Following FDA Setback on Autoimmune Hepatitis Trial

-Kezar Life Sciences, Inc. a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated di...

October 17, 2025 | Friday | News
China NMPA Accepts Belite Bio’s NDA for Tinlarebant with Priority Review Based on Phase 3 DRAGON Interim Data

NMPA’s response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025  Belite Bio, Inc. (NASDAQ...

October 16, 2025 | Thursday | News
Qualio Introduces AI-Powered Compliance Intelligence to Redefine Life Sciences Regulatory Management

AI-powered gap analysis, continuous compliance monitoring, real-time visibility, and pre-built life sciences frameworks help organizations reduce audit p...

October 15, 2025 | Wednesday | News
Zenas BioPharma Secures Global Rights to Orelabrutinib, Expands Pipeline with Novel IL-17AA/AF and TYK2 Inhibitors

Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO) and InnoCare Pharma Limited (&ldqu...

October 09, 2025 | Thursday | News
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
Invivyd Receives FDA Clearance to Advance REVOLUTION Program with Phase 3 DECLARATION and LIBERTY Trials for COVID Prevention

The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clini...

October 07, 2025 | Tuesday | News
Advanz Pharma and Alvotech Secure EMA Acceptance for Xolair® Biosimilar AVT23

Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospita...

October 07, 2025 | Tuesday | News
KARL STORZ Receives FDA Clearance for ENDOFLATOR™ +, the Next Generation in Surgical Insufflation and Smoke Evacuation

KARL STORZ, a global leader in minimally invasive surgical technology, is proud to announce it has received U.S. Food and Drug Administration (FDA) clear...

October 06, 2025 | Monday | News

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