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.
ImCheck Receives EMA Orphan Drug Designation for ICT01 in Acute Myeloid Leukaemia
Tuesday, July 22, 2025ImCheck Therapeutics has received Orphan Drug Designation ODD from the European Medicines Agency EMA for its lead candidate ICT aimed at treating acute myeloid leukaemia AML ICT is a humanised monoclonal
Longeveron® Licences New Cardiac-Targeted Stem Cell Technology for Heart Disease
Tuesday, July 22, 2025Longeveron Inc a clinicalstage biotechnology company focused on regenerative medicine has licensed a newly issued US patent B from the University of Miami The patent covers a specialised stem cell technology
Aldeyra Therapeutics’ Reproxalap NDA for Dry Eye Disease Accepted by FDA
Friday, July 18, 2025Aldeyra Therapeutics Inc has announced that the US Food and Drug Administration FDA has accepted the resubmitted New Drug Application NDA for reproxalap a firstinclass investigational eye drop for the treatment
ENHERTU Plus Pertuzumab Granted U.S. Breakthrough Therapy Designation for First-Line Treatment of HER2 Positive Metastatic Breast Cancer
Friday, July 18, 2025ENHERTU famtrastuzumab deruxtecannxki when used in combination with pertuzumab has been granted Breakthrough Therapy Designation BTD by the US Food and Drug Administration FDA for the firstline treatment of adults with unresectable or metastatic HER...
Thermo Fisher Scientific and Sanofi expand partnership to boost U.S. drug manufacturing capacity
Thursday, July 17, 2025Thermo Fisher Scientific has announced the expansion of its strategic collaboration with Sanofi to strengthen drug product manufacturing capabilities in the United States As part of the agreement
Endeavor BioMedicines receives Orphan Drug Designation for taladegib in the US and EU for idiopathic pulmonary fibrosis
Thursday, July 17, 2025Endeavor BioMedicines a clinicalstage biotechnology company focused on developing treatments for serious diseases has received Orphan Drug Designation for its investigational therapy taladegib ENV
Sanofi's SAR446597 Receives Fast Track Designation in the US for Geographic Atrophy Linked to Age-Related Macular Degeneration
Wednesday, July 16, 2025Sanofi has announced that the US Food and Drug Administration FDA has granted fast track designation to SAR an investigational onetime intravitreal gene therapy for the treatment of geographic atrophy
KalVista Pharmaceuticals Receives UK MHRA Approval for EKTERLY®, the First Oral On-Demand Treatment for Hereditary Angioedema
Wednesday, July 16, 2025KalVista Pharmaceuticals Inc has announced that the UKs Medicines and Healthcare products Regulatory Agency MHRA has granted marketing authorisation for EKTERLY sebetralstat for the treatment of hereditary angioedema HAE attacks in adults and adolesc...
Vertex Secures Reimbursement Deal With NHS England for ALYFTREK® in Cystic Fibrosis Care
Tuesday, July 15, 2025Vertex Pharmaceuticals has announced a broad reimbursement agreement with NHS England for ALYFTREK deutivacaftortezacaftorvanzacaftor a oncedaily combination therapy for cystic fibrosis CF
Boehringer Ingelheim and LEO Pharma Form Partnership to Advance and Commercialise SPEVIGO®
Tuesday, July 15, 2025Boehringer Ingelheim and LEO Pharma have entered into an exclusive global licensing and transfer agreement for the development and commercialisation of SPEVIGO spesolimab
