Topic: Food and Drug Administration

FDA wants more data on Pfizer-Protalix drug

CHICAGO (Reuters) - U.S. health regulators have asked for additional data to support Pfizer Inc's and Protalix Biotherapeutics Inc's new drug application for taliglucerase alfa, a treatment for Gaucher disease, a rare genetic disorder.The news sent Protalix shares tumbling in premarket trading. ...

FDA cites Sanofi over drug side effect reporting

WASHINGTON (Reuters) - The Food and Drug Administration warned Sanofi-Aventis SA's U.S. unit for failing to tell the agency about reports of possible serious side effects in a timely manner.In a January 28 letter made public on Tuesday, the FDA said an ...

Obama budget targets brand name medicines

WASHINGTON (Reuters) - Big pharmaceutical companies could face increased competition from generic drugmakers under two proposals put forth by the Obama administration on Monday despite earlier savings extracted from drugmakers as part of last year's healthcare law.President Barack Obama, as part of ...

Drugmakers could take hit under Obama budget

WASHINGTON (Reuters) - The Obama administration is turning to the pharmaceutical industry to squeeze out more savings to help reduce the deficit and cover other health initiatives such as the implementation of last year's healthcare overhaul.In his fiscal 2012 budget proposal released ...

MannKind says FDA rejects Afrezza diabetes device

BOSTON (Reuters) - MannKind Corp said on Wednesday that U.S. regulators have rejected Afrezza, its experimental device to treat diabetes, and will require two new clinical trials before approving the product.MannKind's shares fell 7.3 percent to $9.11 before being halted pending the ...

FDA to review growth hormone safety, follows EU

WASHINGTON (Reuters) - U.S. health officials are taking a closer look at recombinant human growth hormone products made by Pfizer, Novartis and other drugmakers to see whether they increase the risk of death.The move comes on the heels of a French study ...
FDA warns Forest Laboratories' Tessalon cough capsules look like candy, pose risk to kidsThe U.S. Food and Drug Administration says that Tessalon liquid cough capsules should be kept in child-proof containers because they look like candy and could pose a risk to ...
Valeant Pharmaceuticals International Inc. said Monday that Chairman Bill Wells resigned from the board to pursue other interests.The change comes as Valeant deals with setbacks for two of its most advanced drug candidates.The Canadian drugmaker said board member Robert Ingram has been ...

Supreme Court to decide generic drug labeling issue

WASHINGTON (Reuters) - The U.S. Supreme Court said on Friday that it would decide whether generic drug companies could be sued under state law over allegations they failed to provide adequate label warnings about potential side effects.The nation's highest court will consider ...

AstraZeneca cancer drug carries toxic risks: FDA

An experimental drug developed by AstraZeneca to treat a rare form of thyroid cancer carries "substantial toxicity" risks, the US Food and Drug Administration warned Tuesday.Thirty-one percent of patients taking the drug, vandetanib, experienced serious side effects compared to 13 percent who ...