FDA review

Latest Headlines

Latest Headlines

FDA's boceprevir review spotlights safety concerns

While offering a general endorsement of Merck's ($MRK) claim that its data demonstrates that boceprevir can effectively treat hepatitis C, an FDA staff review released this morning highlights some

Amgen's Prolia wins priority review for cancer use

Amgen's (NASDAQ: AMGN) great new hope--the bone drug Prolia--won priority review at the FDA for a new, potentially lucrative cancer indication. The use: cancer that has spread to bone. The upshot: an

Avandia in the hot seat in EU, US

As the FDA preps for next week's advisory panel review of Avandia, European regulators have launched their own safety probe of the drug. Prompted by new studies released in June linking the

Discovery Labs shares soar on FDA's trial consensus

Shares of Discovery Laboratories (DSCO) shot up 49 percent this morning after the Warrington, PA-based developer reported that the FDA termed its approach to resolving the agency's primary issue with

Panel set to review CombinatoRx drug Exalgo

NASDAQ has halted trading of CombinatoRx's stock today as an FDA advisory committee holds a public meeting to discuss the NDA for Exalgo, a pain drug developed by Neuromed Pharmaceuticals.

Discovery Labs shares boosted as FDA meeting looms

Shares of Discovery Laboratories got a much needed boost after the developer announced plans for a sit-down with FDA regulators over the possibility that a limited trial could supply the agency with

MedImmune: Vaccine ready to go at month's end

MedImmune, which began clinical trials for its swine flu vaccine last month, says the inhaled vaccine could be ready by the end of September. The AstraZeneca subsidiary is now waiting on the FDA to

Merck's Gardasil closes in on broader use

Two out of three ain't bad. Yesterday, Merck's HPV shot Gardasil saw a potential competitor step closer to the market. But it also won an FDA advisory panel recommendation for approval to prevent

FDA experts support apps for Cervarix, Gardasil

In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline's long delayed application to market its HPV vaccine

FDA panel backs GSK's HPV vaccine Cervarix

Two years after swallowing a rejection from the FDA for insufficient data for its human papillomavirus vaccine, GlaxoSmithKline received the support of the agency's expert advisers today.