food and drug administration

Allergan Pays $600 Million to Settle Botox Charges

Pharmaceutical firm Allergan has settled criminal and civil charges that it promoted Botox for uses the FDA hadn't approved, agreeing to pay $600 million and enter into a "corporate integrity agreement." Allergan also dropped its related First Amendment lawsuit against the FDA.

Jazz Shares Fall After FDA Panel Rejects Fibromyalgia Drug

Share of Jazz Pharmaceuticals shares sank over 24% in early morning trading Monday after an FDA advisory panel rejected its proposed fibromyalgia drug, Xyrem, Friday. Though Xyrem appeared to help some patients, the panel found the benefits didn't outweigh the risks.

Deutsche Bank Initiates Coverage of Biotech Stocks

Several biotech stocks were on the move Monday after Deutsche Bank initiated coverage on some of them. The bank's analyst, Robyn Karnauskas, took a generally wary view on the biotech sector, only putting buy ratings on Gilead and Dendreon.

FDA Eyes Overhaul of Medical Device Regulation

The Food and Drug Administration is proposing to revamp its regulations of medical devices, the agency said Wednesday. While seeking to improve device safety, the FDA also wants to ease the regulatory environment and foster innovation. But the proposals have the industry concerned.

Dangerous dietary supplements?

A new report by Consumer Reports Magazine says dietary supplements sold in the U.S. are often contaminated and may cause serious health...

FDA OKs First Trial of Stem Cells to Heal Spine Injuries

The Food and Drug Administration cleared the way on Friday for California biotech firm Geron to begin human clinical trials of its experimental embryonic stem cell-based therapy to heal spinal cord injuries in paraplegic patients.

MannKind Shares Soar on Good News From FDA

MannKind shares jumped about 10% in afternoon trading after the pharmaceutical company announced the Food and Drug Administration accepted its resubmission of its inhaled insulin, Afrezza. The FDA set a review date for Dec. 29.

FDA Panel Rejects Weight-Loss Drug Qnexa

Pharmaceutical company Vivus and investors waited anxiously Thursday for the vote of an FDA advisory panel on the weight-loss drug Qnexa. The verdict is in, and by a vote of 9 to 7, panelists didn't support approving the drug as an obesity treatment.

FDA Panel Votes to Keep Avandia on Market

GlaxoSmithKline's diabetes drug Avandia has been found to have increased heart attack risk compared to other similar medication. But a majority of the Food and Drug Administration's panel of outside experts have voted to keep the drug on the market -- though new restrictions are likely.

GlaxoSmithKline Settles 10,000 Avandia Lawsuits

GlaxoSmithKline, whose diabetes drug Avandia is undergoing a safety review by the FDA, has agreed to pay about $460 million to resolve about 10,000 lawsuits from users of the drug, which can allegedly cause heart attacks and strokes.

FDA Panel Scrutinizing Diabetes Drug Avandia

On Tuesday, the FDA will convene a panel of experts to discuss GlaxoSmithKline's type II diabetes drug Avandia. Once a blockbuster, sales of the drug have dropped by more than half since studies suggested it significantly increases risk for serious heart problems.

FDA sued over lack of action on BPA

A leading environmental group has sued the Food and Drug Administration for dragging its feet on its request 20 months ago to ban the use of...

Avandia Linked to Heart Attacks in Two New Studies

GlaxoSmithKline's diabetes drug Avandia once again captured headlines Monday morning after two new studies linked it to heart attacks and other cardiovascular complications. The authors of the studies say the results should prompt the FDA to pull the drug from the market.

Merck Gets FDA Nod for Asthma Drug

Merck (MRK) today announced that the U.S. Food and Drug Administration has approved its respiratory drug Dulera for Asthma patients 12 years of age and older. Dulera is a new two-in-one, fixed-dose combination, which was developed by Schering-Plough and then inherited by Merck when it acquired its smaller rival last year.

For Food Business, BP Oil
Spill Is a Recipe for Disaster

As the BP (BP) Deepwater Horizon oil spill continues to devastate the Gulf coast fishing industry, worries are growing that contaminated seafood may find its way onto the dinner table. While retailers, restauranteurs and government officials scurry to protect consumers, the full implications of the environmental disaster are beginning to come to light.

Johnson & Johnson Fights Charges of Recalls and Kickbacks

Johnson & Johnson shares are rebounding as the drugmaker tries to recover from a rough week, when the Justice Department charged it with paying kickbacks to a pharmacy company to boost sales of its drugs to nursing-home patients, and the Food and Drug Administration accused it of being too slow with its product recall during a Tylenol scare.

Minnesota Is First to Ban Chemical BPA in Baby Products

The Gopher State will be a happier place for babies come Jan. 1. That's when it enacts the first-ever ban on plastic sippy cups and baby bottles containing Bisphenol-A. The Federal government has yet to act on BPA, a controversial chemical feared to harm fetuses and children.

Crestor Backed by FDA for Patients With Normal Cholesterol

AstraZeneca scored a win on Tuesday, when a Food and Drug Administration advisory panel recommended broader use of Crestor, the company's cholesterol-lowering drug. The panel recommended that those with low cholesterol use the drug, following studies finding that Crestor reduces the risk of heart disease even in those with normal cholesterol levels.