The US Food and Drug Administration has approved bimekizumab, a humanized interleukin (IL)-17A and IL-17F antagonist, for the treatment of adults with moderate to severe hidradenitis […]
Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended refusal of marketing authorizations for: Cinainu (allium/citrus/Paullinia/cacao), an herbal medicine intended to treat moderate to […]
Following a consultation with its emergency task force, the European Medicines Agency (EMA) has backed a drug for adult patients with acute respiratory distress syndrome (ARDS) […]
The European Medicines Agency (EMA) recommended eight medicines for approval this month, including two cancer drugs for treating non-small cell lung cancer (NSCLC). Augtyro for Advanced […]
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Leqembi (lecanemab) to treat mild cognitive impairment […]
The US Food and Drug Administration (FDA) has approved obecabtagene autoleucel, or obe-cel (AUTO1, Autolus Therapeutics) for the treatment of relapsed or refractory adult B-cell acute […]
On November 5, the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about […]
Last month, the US Food and Drug Administration (FDA) approved three new drugs, as well as a potentially practice-changing cancer screening tool, and expanded indications for […]
The European Commission (EC) has fined pharmaceutical company Teva €462.6 million for “systematically spread[ing] misleading information” and abusing its dominant position to delay competition to its […]
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