The approval provides adults aged 45 years and older at average risk of colorectal cancer with an additional blood-based screening option, expanding access for individuals who are overdue for screening.

The approval provides adults and children aged 12 years and older with a single over-the-counter combination option that delivers both rapid and prolonged pain relief without requiring separate analgesic products.

The once-daily treatment introduces the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, with US availability dependent on DEA scheduling.

The non-binding recommendation could create a regulated US compounding route for BPC-157, KPV, TB-500 and MOTS-c, but it does not approve the substances as drugs or establish their safety or effectiveness.

The designation supports development of a one-time investigational gene therapy designed to address the underlying genetic cause of a rare form of dilated cardiomyopathy.

The once-daily tablet provides a new oral option for reducing LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia.

Oral cholesterol therapy offers an alternative to injectable PCSK9 inhibitors as Merck targets multi-billion-dollar cardiovascular market.

The approval of Revtorpyk (gedatolisib) gives Celcuity a new treatment option for HR-positive, HER2-negative breast cancer patients without PIK3CA mutations, following positive Phase III VIKTORIA-1 data showing improved progression-free survival.

The Claria System is designed to improve safety and efficiency during minimally invasive hysterectomy procedures by providing a controlled tissue extraction approach.

iPredict-DR uses artificial intelligence to analyse retinal images and support earlier detection of diabetic eye disease.

Zeta Surgical’s robotic navigation platform uses AI and computer vision to improve precision and repeatability during transcranial magnetic stimulation procedures.

The approvals expand the use of Keytruda and Keytruda Qlex alongside Padcev into the perioperative treatment setting for adults with muscle-invasive bladder cancer.

The FDA has approved Sarclisa Escena, a subcutaneous on-body injector formulation of Sanofi’s multiple myeloma therapy isatuximab, becoming the first cancer treatment authorised in the US for delivery through an on-body injector system. Sanofi has secured US Food and Drug Administration (FDA) approval for Sarclisa Escena, a new subcutaneous (SC) formulation of its multiple myeloma therapy Sarclisa (isatuximab-irfc) delivered through an on-body injector (OBI). The approval rep