Connect to share and comment

FDA staff review raises questions about MannKind diabetes device

WASHINGTON (Reuters) - An initial review of MannKind Corp's experimental inhaled insulin device, Afrezza, by U.S. Food and Drug Administration staff raised multiple questions about its safety and effectiveness in treating diabetes. The reviewers issued their report before a meeting on April 1 of outside advisers to the FDA who will discuss clinical trial data and advise on whether the product should be approved.

FDA panel votes against Novartis drug for acute heart failure

By Toni Clarke (Reuters) - A drug made by Novartis AG to treat acute heart failure should not be approved because there is insufficient evidence it improves symptoms, a panel of advisers to the U.S. Food and Drug Administration concluded on Thursday. The panel's vote was unanimous. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

FDA staff review recommends against Novartis heart failure drug

By Toni Clarke WASHINGTON (Reuters) - A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence to show it improves symptoms, according to an initial review by the U.S. Food and Drug Administration. The review, posted on the FDA's website on Tuesday, comes two days ahead of a meeting of outside advisors who will make their own recommendation on whether the drug should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

Geron says FDA halts patient enrollment in another cancer trial

(Reuters) - Geron Corp said the U.S. Food and Drug Administration ordered a halt to new patient enrollments in an early-stage trial of its blood cancer drug, imetelstat, over concerns about liver damage. The halt announced on Thursday was for enrollments in a trial sponsored by Mayo Clinic, and comes a week after the FDA ordered Geron to cease company-sponsored trials of the drug over similar concerns.

Geron says FDA halts patient enrollment in another cancer trial

(Reuters) - Geron Corp said the U.S. Food and Drug Administration ordered a halt to new patient enrollments in an early-stage trial of its blood cancer drug, imetelstat, over concerns about liver damage. The halt announced on Thursday was for enrollments in a trial sponsored by Mayo Clinic, and comes a week after the FDA ordered Geron to cease company-sponsored trials of the drug over similar concerns.

FDA approves Bristol-Myers' drug for rare fat disorder

(Reuters) - The U.S. Food and Drug Administration said it approved Bristol-Myers Squibb Co's drug to treat rare and potentially fatal disorders involving loss of body fat. The condition, known as generalized lipodystrophy, involves fat buildup in the blood and organs such as liver and muscle and can lead to diabetes, pancreatitis and fatty liver disease. The FDA said it required seven post-marketing studies on the drug, Myalept. (http://r.reuters.com/jam27v) (Reporting by Shailesh Kuber; Editing by Ted Kerr)

FDA rejects wider use of Xarelto drug

By Ransdell Pierson NEW YORK (Reuters) - U.S. health regulators have again declined to approve proposed wider uses of Bayer AG and Johnson & Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday. The companies had sought approval from the U.S. Food and Drug Administration (FDA) to market the blockbuster pill for prevention of new heart attacks and strokes, and death, in patients with acute coronary syndrome (ACS), and also to prevent clogging of heart stents.

Merck's anti-blood clot drug should be approved: FDA review

(Reuters) - Merck & Co Inc's experimental blood clot-preventing drug vorapaxar should be approved, based on "robustly positive" clinical trial results, according to a preliminary review of the data by the U.S. Food and Drug Administration. The review, posted on the FDA's website on Monday, comes two days ahead of a meeting of outside medical experts, who are expected to recommend whether it should be approved. The FDA usually follows the advice of its advisory panels.

FDA urges states, others to register compounding pharmacies under law passed after outbreak

BOSTON - The commissioner of the U.S. Food and Drug Administration has sent letters to state agencies and other stakeholders across the country calling on them to encourage compounding pharmacies to register as producers of sterile drugs in an effort to protect the public.

FDA warns attention deficit drugs may cause long erections

(Reuters) - A leading type of stimulant used to treat attention deficit disorder can cause rare cases of painful and long-lasting erections, the U.S. Food and Drug Administration warned on Tuesday. The agency, in a notice on its website, said its review documented the problem, formally known as priapism, in males 8 to 33 years of age who took drugs containing methylphenidate. The chemical is the active ingredient of Novartis AG's Ritalin and Johnson & Johnson's Concerta. Generic forms of both drugs are also widely used.
Syndicate content