The U.S. health regulator’s staff flagged concerns that data on Merck’s chronic cough drug might not be enough to prove the treatment’s meaningful benefit, documents released ahead of a meeting of independent experts showed.
Tag Archive for: FDA
DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the U.S. Food and Drug Administration (FDA) on manufacturing concerns.
In the letter dated Nov. 13, FDA said Amazon was selling eye drops which have not been recognized as safe and effective for providing temporary relief from eye symptoms such as excessive watery discharge, redness, burning, or pink eye.
The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine.
The regulator’s advisory committee on Tuesday found Vertex Pharmaceuticals and CRISPR Therapeutics’ off-target analysis for its sickle cell disease candidate exa-cel to be sufficient.
In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.
The agency’s staff reviewers said it was not clear if the limited donor cells used for assessment were adequate to evaluate the potential safety risks of the therapy.
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
