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.
EU Lawmakers Agree Deal on Long-Awaited Pharma Reform Package
Friday, December 12, 2025EU lawmakers have reached an agreement on the longawaited pharmaceutical reform package balancing innovation incentives with patient access across Europe
EU institutions reach historic political agreement on major reform of pharmaceutical legislation
Thursday, December 11, 2025EU legislators have reached a political agreement on the first major overhaul of EU pharmaceutical legislation in years reshaping incentives market access and supply obligations for the European life sciences industry
Formycon and Zydus Sign Exclusive Licensing and Supply Agreement for FYB206, a Biosimilar to Keytruda®, in the U.S. and Canada
Wednesday, December 10, 2025Formycon AG and Zydus Lifesciences have entered into a strategic partnership covering the exclusive licensing and supply of FYB a biosimilar version of pembrolizumab Keytruda for the US and Canadian markets
FDA Grants Breakthrough Therapy Designation to Investigational Drug Adrabetadex for Infantile-Onset Niemann-Pick Disease Type C
Wednesday, December 10, 2025Beren Therapeutics through its subsidiary Mandos LLC has received Breakthrough Therapy Designation BTD from the US Food and Drug Administration FDA for adrabetadex
Evotec Completes Strategic Sale of Just Evotec Biologics Toulouse Biomanufacturing Site to Sandoz to Expand European Biosimilar Capacity
Monday, December 08, 2025Evotec has closed the sale of its Just Evotec Biologics Toulouse site and granted a license to its continuous biologics manufacturing technology to Sandoz strengthening European biosimilar development and manufacturing capacity
Bristol Myers Squibb’s Breyanzi Receives U.S. FDA Approval as the First CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma
Friday, December 05, 2025Bristol Myers Squibb has received approval from the US Food and Drug Administration FDA for Breyanzi a CDdirected CAR T cell therapy The treatment is authorised for adults with relapsed or refractory marginal zone lymphoma MZL
UK life sciences sector set to benefit from new zero-tariff US pharmaceuticals trade deal and increased investment in innovative medicines
Friday, December 05, 2025The UK government has agreed a zerotariff pharmaceuticals trade deal with the US and pledged higher investment in innovative medicines reinforcing Europes life sciences competitiveness and manufacturing base
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
