Insmed Announces Landmark Phase 3 ASPEN Study Results Demonstrating Brensocatib’s Breakthrough Potential in Bronchiectasis

Insmed Incorporated, a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patie...

April 24, 2025 | Thursday | News
Argent BioPharma Enters German Market with CannEpil® and CogniCann® Following Regulatory Approval

Argent BioPharma Ltd. , a clinical-stage biopharmaceutical company specializing in neuroimmune therapies, is pleased to announce its official entry into th...

April 24, 2025 | Thursday | News
Dupixent Secures FDA Nod for Chronic Spontaneous Urticaria in Patients Unresponsive to Antihistamines

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,0...

April 21, 2025 | Monday | News
Daiichi Sankyo and AstraZeneca’s ENHERTU Combo Outperforms Standard of Care in First-Line HER2+ Metastatic Breast Cancer

DESTINY-Breast09 phase 3 trial of Daiichi Sankyo and AstraZeneca’s ENHERTU is the first trial in more than a decade to demonstrate superior eff...

April 21, 2025 | Monday | News
Akeso Secures NMPA Approval for Ebdarokimab to Treat Moderate-to-Severe Plaque Psoriasis in Adults

Akeso, Inc. is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from ...

April 21, 2025 | Monday | News
Eisai and Biogen’s Leqembi® Becomes First Alzheimer’s Therapy Approved in EU to Target Disease Pathology

Eisai Co., Ltd. and Biogen Inc. announced that the European Commission (EC) has granted marketing authorization (MA) for Leqembi® (lecanemab), a m...

April 17, 2025 | Thursday | News
Pfizer Applauds CDC Panel’s Expanded Recommendation for RSV Vaccination in At-Risk Adults Aged 50–59

Pfizer Inc. announced  that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) vote...

April 17, 2025 | Thursday | News
Biocon Biologics Clears U.S. Path for Interchangeable Aflibercept Biosimilar Yesafili Through Regeneron Settlement

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd announced  a settlement and license agreement...

April 16, 2025 | Wednesday | News
Lecanemab Becomes First Approved Disease-Modifying Therapy for Early Alzheimer’s in the EU

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild de...

April 16, 2025 | Wednesday | News
Certara Launches Non-Animal Navigator™ to Accelerate Ethical, Predictive Drug Development

Certara, Inc. a global leader in model-informed drug development, announced the launch of its Non-Animal Navigator™ solution designed to help bi...

April 16, 2025 | Wednesday | News
ACRO Biomedical Gets Taiwan MOHW Nod for ABCcolla® Collagen Eye Matrix

ACRO Biomedical Co.,  announced that its ABCcolla® Collagen Ophthalmic Matrix has received regulatory approval from Taiwan's&n...

April 14, 2025 | Monday | News
Roche Secures EU Approval for Columvi Combo as First Bispecific Antibody Regimen for Relapsed DLBCL

Approval based on Phase III STARGLO study where Columvi in combination with chemotherapy showed a 41% reduction in the risk of death compared to MabThe...

April 14, 2025 | Monday | Regulatory
Sandoz Sues Amgen in US Antitrust Case Over Enbrel® Patent Practices

Sandoz , the global leader in generic and biosimilar medicines,  announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen),...

April 14, 2025 | Monday | News
AbbVie’s RINVOQ® Becomes First Oral JAK Inhibitor Approved in EU for Giant Cell Arteritis

AbbVie announced that the European Commission (EC) granted marketing authorization to RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment ...

April 10, 2025 | Thursday | News

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