October 18, 2024
In its October 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for Korjuny (catumaxomab, Lindis […]
October 18, 2024
A new diagnostic tool for detecting Mycobacterium tuberculosis infection should be granted a marketing authorization, the European Medicines Agency (EMA) has said. On October 17, the EMA’s […]
October 17, 2024
Medtronic has issued a second alert letter to patients regarding shortened battery life of the MiniMed 600 and 700 series insulin pumps. The affected products include […]
October 17, 2024
The US Food and Drug Administration (FDA) has approved Avadel Pharmaceuticals’ supplemental new drug application for extended-release sodium oxybate (Lumryz) for treatment of cataplexy or excessive […]
October 15, 2024
The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (Imuldosa) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is […]
October 11, 2024
The US Food and Drug Administration (FDA) has approved inavolisib (Itovebi, Genentech) in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, hormone receptor–positive (HR+), human epidermal […]
October 4, 2024
The US Food and Drug Administration (FDA) approved Exact Sciences’ next-generation multitarget stool DNA (mt-sDNA) test, Cologuard Plus, for use in adults 45 or older who […]
October 1, 2024
The European Commission has approved the topical pan-JAK inhibitor delgocitinib for adults with moderate to severe hand eczema, for whom topical corticosteroids are inadequate or inappropriate, […]
September 27, 2024
The US Food and Drug Administration (FDA) has approved Cobenfy (Bristol Myers Squibb), a first-in-class antipsychotic approved for schizophrenia. The drug targets cholinergic receptors as opposed […]