Medtronic plc received U.S. FDA approval for Altaviva, a minimally invasive implantable tibial neuromodulation device designed to treat urge urinary incontinence. Insertion near the ankle requires neither sedation nor imaging and patients walk out the clinic door with the device already activated.
Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.
Endocyclic Therapeutics (Endomet Biosciences Inc.) has been awarded a National Institute of Health (NIH) Commercialization Readiness Pilot (CRP) Program grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to accelerate the commercialization of ENDO-205, a nonhormonal, disease-modifying therapeutic designed to treat endometriosis.