Merck Inc.,, known as MSD outside of the United States and Canada, announced that the FDA has approved sotatercept-csrk (U.S. Brand Name: Winrevair, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
Mavenclad (cladribine tablets) from Merck KGaA, is now indicated for the treatment of adult patients with relapsing forms of Multiple Sclerosis (MS) with active disease as defined by clinical or imaging features following approval by the MHRA, meaning more newly diagnosed patients could be eligible for treatment earlier in their disease course.
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy.