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FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease
Eisai and Biogen announced today that the US Food and Drug Administration (FDA) has accepted […]
Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis
Regeneron Pharmaceuticals and Sanofi today announced that the European Commission (EC) has approved Dupixent (dupilumab) […]
Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis
Regeneron Pharmaceuticals and Sanofi today announced that the European Commission (EC) expanded the marketing authorization […]
Poxel Receives Orphan Drug Designation from the European Commission for PXL770 and PXL065 for Treatment of Adrenoleukodystrophy
POXEL SA, a clinical-stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic […]
ADC Therapeutics and Sobi Announce European Commission Approval of ZYNLONTA® for the Treatment of Lymphoma
ADC Therapeutics SA and Swedish Orphan Biovitrum AB (Sobi) has announced the European Commission (EC) […]
Novavax and European Commission Finalize Advance Purchase Agreement for up to 200 Million Doses of COVID-19 Vaccine
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today […]
EU Digital COVID Certificate: EU Gateway Goes Live with Seven Countries One Month Ahead of Deadline
Today, the EU Digital COVID Certificate has reached another important milestone with the go-live of the technical […]
- Axel Hoos, MD, PhD, Joins NextPoint Therapeutics Board of Directors Read more
- Coya Therapeutics Announces Positive Results from a Proof-of-Concept Academic Clinical Study for COYA 302 in Amyotrophic Lateral Sclerosis (ALS) Read more
- BeiGene Enters New Phase to Expand US Manufacturing and R&D Footprint in New Jersey Read more
- Mindset Health Raises $12M to Expand Digital Hypnotherapy Apps & Scale Distribution Read more
- GeneDx Announces Progress on GUARDIAN Study and Promise of Early Genomic Testing to End Rare Disease “Diagnostic Odyssey” Read more