Tag:

Tafamidis

Latest Headlines

Latest Headlines

FDA panel mixed on Pfizer's rare disease drug

Pfizer's pioneering rare-disease drug tafamidis garnered mixed reviews from FDA advisers Thursday, casting further uncertainty over whether the agency will green-light the treatment for the U.S. market.

UPDATED: In rare slap, FDA review rips up Pfizer's case for tafamidis

After considering the trial's failure to meet its co-primary endpoints and questioning the data gathered at 8 sites, the agency is recommending that the experts gathering to discuss the drug's fate on Thursday reject the therapy.

Pfizer grabs leg up in pursuit of rare disease drug win

The FDA has given pharma giant Pfizer ( $PFE ) a fast-track review of its drug tafamidis meglumine for treating the rare disease known as transthyretin familial amyloid polyneuropathy, meaning the...

Pfizer, J&J grab CHMP backing for key new drugs

Johnson & Johnson ( $JNJ ) and Pfizer ( $PFE ) are among the developers that have received positive opinions of new drugs under review for EU approval. For Vertex Pharmaceuticals ( $VRTX ) and partner

Pfizer, FoldRx drug extends survival

Data from a Phase II/III trial of transthyretin familial amyloid polyneuropathy (TTR-FAP) showed that Pfizer and FoldRx's drug tafamidis slowed disease progression over 30 months. No safety concerns