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.
Evinova Announces Strategic Collaborations with Astellas Pharma
Thursday, February 19, 2026Evinova has announced strategic collaborations with Astellas Pharma to advance global life sciences initiatives in Europe
Harmony Biosciences Secures U.S. FDA Approval for WAKIX® (pitolisant) to Treat Cataplexy in Paediatric Narcolepsy
Wednesday, February 18, 2026Harmony Biosciences has received approval from the US Food and Drug Administration for its supplemental new drug application sNDA for WAKIX pitolisant tablets to treat cataplexy in paediatric patients aged six years and older with narcolepsy
Deciphera Pharmaceuticals Announces U.S. FDA Acceptance of NDA for Tirabrutinib in Relapsed or Refractory PCNSL
Wednesday, February 18, 2026Deciphera Pharmaceuticals a member of Ono Pharmaceutical Co Ltd has announced that the US Food and Drug Administration has accepted for filing its New Drug Application NDA for tirabrutinib under the accelerated approval pathway
HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer
Tuesday, February 17, 2026HanchorBio Inc has received Orphan Drug Designation from the US Food and Drug Administration for HCB to treat gastric cancer The designation applies to gastric cancer broadly including advanced gastric adenocarcinoma in both HERpositive and HERnegati...
EU Parliament Advances Critical Medicines Act to Bolster Europe's Medicine Supply Security in 2026
Tuesday, February 17, 2026The EU Parliament has advanced the Critical Medicines Act aimed at strengthening Europes pharmaceutical supply chain resilience and medicine security starting in
EMA Recommends Withdrawal of Marketing Authorisations for Levamisole Medicines
Monday, February 16, 2026The European Medicines Agency has recommended the withdrawal of marketing authorisations for levamisolecontaining medicines due to safety concerns
Nxera Pharma Announces Operational Highlights and Consolidated Financial Results for Q4 and Full Year 2025
Friday, February 13, 2026Nxera Pharma released its operational highlights and consolidated financial results for the fourth quarter and full year outlining key advancements in its European biopharma pipeline
U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer
Thursday, February 12, 2026Novocure has received approval from the US Food and Drug Administration FDA for Optune Pax for the treatment of adults with locally advanced pancreatic cancer The device is approved for use together
EU Pharmacovigilance Regulation Changes Effective February 12, 2026 Impact UK and EU Authorised Medicines
Thursday, February 12, 2026From February amendments to EU Commission Implementing Regulation take effect altering pharmacovigilance requirements for UKauthorised medicines held by companies with dual UKEU licences
Kincell Bio Partners with RegCell to Support Clinical Development of Treg Cell Therapies for Autoimmune Diseases
Wednesday, February 11, 2026Kincell Bio a USbased cell therapy contract development and manufacturing organisation CDMO has announced a collaboration with RegCell a biotechnology company developing an immune tolerance platform