Biotech | February 13, 2021
Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
The centralized marketing authorization granted by the EC is valid in all EU Member
The centralized marketing authorization granted by the EC is valid in all EU Member
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue
This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
Subscribe To Our Newsletter & Stay Updated
_256_275.jpg)