On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
The U.S. Food and Drug Administration has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria.
EMA’s human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool, called AIM-NASH, helps pathologists analyse liver biopsy scans to identify the severity of MASH (metabolic dysfunction associated steatohepatitis; formerly known as non-alcoholic steatohepatitis NASH) in clinical trials.
On March 20, 2025 the U.S. Food and Drug Administration announced the over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) facility fee rates for fiscal year (FY) 2025 in a Federal Register notice (FRN) titled “Over-the-Counter Monograph Drug User Fee Program – Facility Fee Rates for Fiscal Year 2025.” This FRN publishes annual OMUFA fees for …
New results from a trial investigating a synthetic form of psilocybin, administered with psychological support, showed that it extended the time participants with treatment-resistant depression (TRD) were free from depressive symptoms. A single 25mg dose of COMP360 psilocybin had benefit over smaller 1mg and 10mg doses in the 52-week COMP004 follow-up study to the Phase …
EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA and the EMA Management Board. The strategy, titled ‘Seizing opportunities in a changing medicines landscape’, will guide the European medicines regulatory network over the next few years to …
Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028 Read More »
On March 19, 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
