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
FDA Approves Opdivo® Plus Yervoy® as First-Line Treatment for MSI-H/dMMR Metastatic Colorectal Cancer

 Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy®...

April 10, 2025 | Thursday | News
South Korea Makes History with World’s First Recombinant Anthrax Vaccine Approval

GC Biopharma announced 09. Apr. 2025 that the Korean Ministry of Food and Drug Safety (MFDS) has approved its anthrax vaccine, BARYTHRAX, jointly develop...

April 09, 2025 | Wednesday | News
Halozyme’s ENHANZE® Technology Powers European Approval of Subcutaneous RYBREVANT® for Advanced NSCLC Treatment

 Halozyme Therapeutics, Inc.announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) mark...

April 08, 2025 | Tuesday | News
AstraZeneca’s Imfinzi (Durvalumab) Gains European Union Approval for Resectable Non-Small Cell Lung Cancer Treatment

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the European Union (EU) for the treatment of adult...

April 07, 2025 | Monday | News
Pillar Biosciences Secures U.S. Nationwide Medicare Coverage for oncoReveal® CDx Pan-Cancer NGS Kit

 Pillar Biosciences, Inc., the leader in Decision Medicine™,  announced they have received nationwide Medicare coverage by the Centers fo...

April 04, 2025 | Friday | News

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