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 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 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