RemeGen and Santen Forge Strategic Alliance to Advance RC28-E for Retinal Diseases Across Asia

RemeGen Co., Ltd, a leading Chinese biopharmaceutical company, announced today that it has entered into an agreement with Santen Pharmaceutical (China) C...

August 19, 2025 | Tuesday | 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
Align Technology Files Global Patent Infringement Lawsuits Against Angelalign

Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign...

August 19, 2025 | Tuesday | News
European Commission Approves OGSIVEO® as First-Ever Therapy for Desmoid Tumours

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced that the European Commission (EC) granted marketing aut...

August 19, 2025 | Tuesday | Regulatory
Enable Injections Wins ANVISA Approval for enFuse® On-Body Drug Delivery System in Brazil

Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse® on-body drug deliv...

August 14, 2025 | Thursday | News
Dräger’s Atlan A350/A350XL Anesthesia Workstations Achieve U.S. DoD ATO Certification for Maximum Patient Data Security

Certification ensures highest level of patient data security a medical device can attain Effective 7/14/2025 and expiring on 7/14/2028 under eMASS ...

August 12, 2025 | Tuesday | News
China’s Kexing Biopharm Forms Strategic Alliance with IQVIA to Accelerate Global Drug Development and Commercialisation

 Kexing Biopharm (688136.SH) has officially entered into a comprehensive strategic partnership with IQVIA(NYSE:IQV), a global leader in clinica...

August 12, 2025 | Tuesday | News
Fosun Pharma Grants Global Rights (Ex-China) for Innovative Respiratory Drug XH-S004 to Expedition Therapeutics

Fosun Pharma (SSE:600196, HKEX: 02196) announced that its subsidiary Fosun Pharma Industrial has signed a License Agreement with Expedition Therapeutics ...

August 12, 2025 | Tuesday | News
Junshi Biosciences’ sNDA for Toripalimab Plus Disitamab Vedotin in HER2-Expressing Urothelial Carcinoma Accepted by China’s NMPA

Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to th...

August 11, 2025 | Monday | News
Nyxoah Secures FDA Approval for Genio System to Treat Moderate to Severe Obstructive Sleep Apnea

Nyxoah SA , a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, ann...

August 11, 2025 | Monday | News
Avobis Bio Seeks FDA RMAT Designation for AVB-114 Following Positive Phase II Results

Analysis leads to FDA RMAT submission and late-breaking abstract for implantable cell therapy - Avobis Bio LLC, a clinical stage company developing impl...

August 08, 2025 | Friday | News
Bristol Myers Squibb’s Breyanzi Granted FDA Priority Review for Relapsed or Refractory Marginal Zone Lymphoma

Breyanzi has the potential to be the first and only CAR T cell therapy approved for MZL, addressing a high unmet need Application based on results fro...

August 05, 2025 | Tuesday | News
Taiwan’s Anbogen Therapeutics Receives FDA IND Approval to Initiate Global Phase 1/2 Trial for ABT-301 in Metastatic Colorectal Cancer

Anbogen Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, ...

August 04, 2025 | Monday | News
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

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