In its July 2024 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended not granting marketing authorization for […]

The European Medicines Agency (EMA) has recommended that a conditional marketing authorization should be granted for Iqirvo (elafibranor; Ipsen Pharma) for treating primary biliary cholangitis (PBC). […]

The US Food and Drug Administration (FDA) recently approved two biosimilars to Soliris for the treatment of two rare diseases — paroxysmal nocturnal hemoglobinuria (PNH), a […]

The US Food and Drug Administration (FDA) approved Voquezna (vonoprazan, Phathom Pharmaceuticals) 10-mg tablets for the relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) […]

Inspire Medical Systems has issued a recall for the Inspire IV Implantable Pulse Generator (IPG) Model 3028 because of a manufacturing defect that could disrupt therapy […]

The US Food and Drug Administration (FDA) has updated its information related to recalls of the Philips Respironics, Inc. OmniLab Advanced+ (OLA+) Ventilator to reflect an […]

On July 9, the US Food and Drug Administration approved the supplemental new drug application for roflumilast cream 0.15% for the treatment of mild to moderate […]

The US Food and Drug Administration (FDA) has approved Eli Lilly’s anti-amyloid donanemab (Kisunla) 350 mg/20 mL once-monthly injection for intravenous infusion for adults with early […]

The US Food and Drug Administration (FDA) has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. In addition, […]