Trump Chooses White House Health Adviser Heidi Overton to Take Charge of the FDA
President Donald Trump has nominated Dr. Heidi Overton, a senior White House health-policy adviser and physician, to become the next commissioner of the U.S. Food and Drug Administration, placing a trusted administration figure in line to lead one of the country’s most consequential public-health agencies. Overton’s nomination comes during a turbulent period for the FDA, […]
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. […]
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 […]
