News
The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.
Ionis Receives U.S. FDA Breakthrough Therapy Designation for Zilganersen for Alexander Disease
Wednesday, December 03, 2025Ionis Pharmaceuticals has announced that the US Food and Drug Administration FDA has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease AxD AxD is a rare
Celltrion Announces U.S. FDA Approval of 300 mg Strength of OMLYCLO®, the First and Only Interchangeable Biosimilar to XOLAIR®
Wednesday, December 03, 2025Celltrion has received approval from the US Food and Drug Administration FDA for a new mg mL presentation of OMLYCLO omalizumabigec OMLYCLO is the first and only FDAapproved biosimilar that is considered interchangeable
Solid Biosciences Receives FDA Rare Pediatric Disease Designation for SGT-212 Dual Route Gene Therapy for Friedreich’s Ataxia
Tuesday, December 02, 2025Solid Biosciences has received Rare Pediatric Disease designation from the US Food and Drug Administration FDA for SGT its investigational gene therapy for Friedreichs ataxia FA The therapy is designed to deliver the fulllength
Regeneron and Tessera Therapeutics to Jointly Develop TSRA-196, an Investigational Gene Editing Therapy for Alpha-1 Antitrypsin Deficiency (AATD)
Tuesday, December 02, 2025Regeneron Pharmaceuticals and Tessera Therapeutics have entered into a global collaboration to develop and commercialise TSRA Tesseras lead in vivo Gene Writing therapy for alpha antitrypsin deficiency
U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Thursday, November 27, 2025BeOne Medicines Ltd has announced that the US Food and Drug Administration FDA has accepted and granted Priority Review to the New Drug Application NDA for sonrotoclax This nextgeneration BCL inhibitor
Teva Receives European Commission Approval for PONLIMSI® and DEGEVMA®, Biosimilars to Prolia® and Xgeva®
Wednesday, November 26, 2025Teva Pharmaceuticals International GmbH a subsidiary of Teva Pharmaceutical Industries Ltd has received marketing authorisation from the European Commission EC for its two denosumab biosimilars PONLIMSI a biosimilar to Prolia
Harbour BioMed strengthens global collaboration with AstraZeneca to advance next-generation oncology biotherapeutics
Tuesday, November 25, 2025Harbour BioMeda global biopharmaceutical company focused on developing novel antibody therapies for immunology and oncology has announced progress and expansion in its strategic collaboration with AstraZeneca first launched
Bristol Myers Squibb receives European Commission approval to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma
Tuesday, November 25, 2025Bristol Myers Squibb announced that the European Commission EC has granted approval to Breyanzi lisocabtagene maraleucel lisocel a CDdirected chimeric antigen receptor CAR T cell therapy for the treatment of adult patients with relapsed or refractory...
Harbour BioMed Advances Global Strategic Collaboration With AstraZeneca to Discover and Develop Next-Generation Biotherapeutics in Oncology
Monday, November 24, 2025Harbour BioMed and AstraZeneca have advanced their European strategic partnership to focus on nextgeneration antibody therapeutics in oncology targeting accelerated discovery development and commercialization of biotherapeutics across the region
AGC Biologics and Repair Biotechnologies Form Partnership to Advance Novel mRNA Therapy Targeting Atherosclerosis
Friday, November 21, 2025AGC Biologics has announced a new partnership with Repair Biotechnologies to develop and manufacture an innovative mRNA therapy aimed at reducing atherosclerotic plaque a major cause of heart attacks and strokes
