Cryoport Sets New Industry Benchmark as First Supply Chain Solutions Provider Certified Under ISO 21973

First Global Supply Chain Solutions Company to Achieve ISO 21973 Certification, Ensuring Highest Transport Safety, Traceability, and Integrity Standards ...

October 31, 2025 | Friday | News
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

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