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.

Cosmo Pharmaceuticals Receives CE Certification for ColonPRO EU, Europe’s Most Advanced AI Colonoscopy Platform

Monday, November 03, 2025

Cosmo Pharmaceuticals has received CE certification for ColonPRO EU marking a major leap in AIpowered colonoscopy across Europe

Calluna Pharma Receives U.S. FDA Orphan Drug Designation for CAL101 in Idiopathic Pulmonary Fibrosis

Saturday, November 01, 2025

Calluna Pharma AS a clinicalstage biotechnology company focused on developing novel antibodies for inflammatory and fibrotic diseases has received Orphan Drug Designation from the US Food and Drug Administration FDA for CAL

NLS Pharmaceutics Expands CNS Pipeline with AEX-6xx Series Developed by Aexon Labs

Friday, October 31, 2025

NLS Pharmaceutics Ltd a Swiss clinicalstage biopharmaceutical company specialising in central nervous system CNS and neurodegenerative disorders together with Aexon Labs a biotechnology company focused

Vertex Pharmaceuticals and NHS England Reach Landmark Reimbursement Agreement for ALYFTREK in Cystic Fibrosis, Pioneering Access to Once-Daily Combination Therapy Across the UK

Friday, October 31, 2025

Vertex Pharmaceuticals has finalized a UKwide reimbursement deal with NHS England for ALYFTREK enabling broader access to its new cystic fibrosis therapy

Amneal receives U.S. FDA tentative approval for beclomethasone dipropionate HFA inhalation aerosol

Thursday, October 30, 2025

Amneal Pharmaceuticals Inc has announced that the US Food and Drug Administration FDA has granted tentative approval for the companys Abbreviated New Drug Application ANDA for beclomethasone dipropionate

FDA grants Orphan Drug Designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer

Thursday, October 30, 2025

Dewpoint Therapeutics has announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation ODD to DPTX its firstinclass condensate modulator developed for the treatment of gastric cancer

European Union Unveils Ambitious Life Science Growth Strategy to Cement Global Leadership by 2030

Thursday, October 30, 2025

The European Union has launched a sweeping strategic initiative aimed at making Europe the worlds leading region for life sciences by with major investments regulatory reforms and sectorwide incentives

Harbour BioMed Introduces First Fully Human Generative AI HCAb Model to Advance Biologics Discovery

Wednesday, October 29, 2025

Harbour BioMed a global biopharmaceutical company specialising in antibody therapeutics for immunology and oncology has launched its first fully human Generative AI HCAb Heavy ChainOnly Antibody Model

Enigma Biomedical USA Announces FDA Acceptance of New Drug Application for Florquinitau F-18 (MK-6240), a Tau PET Radiodiagnostic for Alzheimer’s Disease

Wednesday, October 29, 2025

Enigma Biomedical USA EB USA has announced that the US Food and Drug Administration FDA has accepted the New Drug Application NDA for florquinitau F MK a Tau Positron Emission Tomography

European Commission Opens Biotech and Biomanufacturing Hub to Accelerate EU Life Sciences Innovation

Wednesday, October 29, 2025

The European Commission announced the opening of a Biotech and Biomanufacturing Hub to drive pharmaceutical innovation and support SMEs across the European Union