Pharma News

The U.S. Food and Drug Administration (FDA) is recommending an additional, earlier magnetic resonance imaging (MRI) monitoring prior to the 3rd infusion for patients with Alzheimer’s disease taking Leqembi (lecanemab). The earlier monitoring can identify individuals with amyloid-related imaging abnormalities with edema (ARIA-E), which is characterized by brain swelling or fluid buildup. ARIA-E is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, can occur and there have been deaths.

Sandoz the global leader in generic and biosimilar medicines, today announced the launch of generic rivaroxaban in Germany, in new generic strengths of 10 mg, 15 mg and 20 mg. Rivaroxaban - 1 A Pharma® offers patients in Germany a high-quality, affordable alternative to reference product Xarelto®*, with a list price advantage across all three strengths.

In its 25th meeting held on 06.08.2025 at CDSCO Headquarters, New Delhi, the Subject Expert Committee (SEC) on Oncology recommended approval for Dr. Reddy’s Laboratories to import and market Olutasidenib Capsules.

US Food and Drug Administration (FDA) approved olutasidenib capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.