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Hope Medicine wins FDA Fast Track Designation for HMI-115 in endometriosis
4 December 2025 - China-based biopharmaceutical company Hope Medicine Inc. on Thursday said its lead candidate HMI-115 has received Fast Track Designation from the US Food and Drug Administration for moderate to severe endometriosis-associated pain.H...
MED-EL cochlear implant FDA approved for children 7 months and older
4 December 2025 - Implantable hearing solutions provider Medical Electronics (MED-EL USA) announced on Thursday that the US Food and Drug Administration (FDA) has approved its cochlear implants for children 7 months and older with bilateral sensorine...
Bayer launches Phase IIa trial of BAY 3401016 for Alport Syndrome
4 December 2025 - German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) announced on Thursday that it has initiated a Phase IIa clinical trial of BAY 3401016, an investigational monoclonal antibody designed to block Semaphor...
Orano Med and Roche advance pretargeted radioimmunotherapy into clinical phase
4 December 2025 - Orano Med, a subsidiary of the Orano group with a focus on nuclear medicine, announced on Thursday that its collaboration with Swiss biotechnology company Roche (SIX: RO, ROG; OTCQX: RHHBY) is entering the next phase, moving pretarg...
New Leqembi data indicates substantial delays in Alzheimer's progression
4 December 2025 - Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai Co Ltd (TYO:4523) on Thursday reported new data on lecanemab (Leqembi) showing potential to delay progression from mild cognitive impa...