Grail’s Galleri Cancer Test Faces Landmark FDA Review After Mixed Clinical Results
Grail’s ambitious effort to transform cancer screening is approaching a pivotal regulatory moment. The U.S. Food and Drug Administration has scheduled an advisory committee meeting for September 23, 2026, to evaluate the company’s Galleri multi-cancer early detection blood test. It will be the first FDA advisory panel convened to consider a premarket approval application for […]
FDA Unexpectedly Rejects Promising Cancer Therapy Over Manufacturing Concerns
The U.S. Food and Drug Administration has unexpectedly rejected ITM-11, an experimental radiopharmaceutical developed by Germany’s ITM Isotope Technologies Munich for patients with gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. The decision represents a significant setback for ITM and delays the arrival of a treatment expected to become an important competitor to Novartis’ established radiopharmaceutical therapy Lutathera. […]
Medics wait for US FDA decision on FMT treatment
Peggy Lillis Foundation (PLF) has being helping to spread awareness regarding Clostridioides difficile, or ‘C. diff’. In the U.S. there is, currently, a pending decision that could impact the care of patients with C. diff and limit the options they have to prevent recurrent infections. The U.S. Food and Drug Administration (FDA) has until the […]
Key ingredient used in cold and cough medicines ineffective for congestion relief, FDA panel says
Popular versions of cold and cough medications such as Sudafed are ineffective for congestion relief, according to a US drug advisory panel. An FDA advisory panel voted on Tuesday against the effectiveness of phenylephrine – the key drug found in many over-the-counter cough and cold medicines – when taken orally. The FDA assembled its outside […]
Appeals court can rule at any time in dispute over suspending FDA approval of medication abortion drug
The Justice Department and a manufacturer of abortion pills have submitted the final round of court briefs in the emergency dispute over whether an appeals court should freeze a judge’s ruling that would suspend the Food and Drug Administration’s approval of medication abortion drugs. Now that the filings have been submitted, the US 5th Circuit […]
