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Pfizer Inc. said Friday the Food and Drug Administration approved Geodon as a part of a combination maintenance treatment for bipolar disorder in adults.
Drug developer Pfizer Inc. said Friday the Food and Drug Administration approved an intravenous version of its high blood pressure drug Revatio.
Health care company Covidien PLC said Friday the Food and Drug Administration will take longer than expected to review the potential opioid pain drug Exalgo.
Biotechnology company Dendreon Corp. said Friday the Food and Drug Administration will make a regulatory decision on the potential prostate cancer vaccine Provenge by May 1.
The Food and Drug Administration said Thursday it issued 22 warning letters to Web site operators over alleged illegal sales of unapproved or misbranded drugs.
Genentech Inc. and partner Biogen Idec Inc. said Wednesday the Food and Drug Administration is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further discussion.
Medtronic said Wednesday it is responding to a warning letter from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division.
Shares of biotechnology company NeurogesX Inc. jumped Tuesday after the company received Food and Drug Administration approval for its Qutenza pain patch.
Human Genome Sciences Inc. said Monday the Food and Drug Administration will not approve the company's anthrax treatment until it receives additional information on the potential drug.
Genzyme Corp. said Monday the Food and Drug Administration will not approve the potential Pompe disease treatment Lumizyme until the company fixes manufacturing problems at the company's Boston-area facility.
The Food and Drug Administration is challenging makers of alcohol-infused energy drinks to prove their beverages are safe, citing complaints that the products can cause risky behavior and injury.
In a Nov. 9 story and headline about a Food and Drug Administration review of a drug being developed by XenoPort Inc. and GlaxoSmithKline PLC, The Associated Press reported erroneously on the nature of the FDA review. The FDA is considering an application for the drug in restless legs syndrome, not neuropathic pain.
Teva Pharmaceutical Industries Ltd. said Tuesday the Food and Drug Administration approved its generic version of the heartburn drug Prevacid.
The Food and Drug Administration needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC, the companies said.
The Food and Drug Administration said Friday that it has warned several companies to stop selling banned flavored cigarettes to U.S. consumers online.
The Food and Drug Administration is launching a program to try and prevent millions of accidental drug overdoses that occur each year due to medication errors, misuse and other problems.
The U.S. Food and Drug Administration sent a warning letter Friday to Procter & Gamble Co. saying the company was illegally marketing two Vicks cold and flu medicines containing vitamin C.
Gen-Probe Inc. said Thursday the Food and Drug Administration granted emergency approval to its diagnostic test for the 2009 swine flu.
Unilever PLC said late Monday it has decided to phase out use of the Smart Choices logo on its food and beverage products now that the Food and Drug Administration plans to standardize criteria for food nutrition labels.
The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives, say congressional investigators.
Shire PLC said the U.S. Food and Drug Administration reaffirmed a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity.
The Food and Drug Administration says Human Genome Sciences' ABthrax successfully treated animals exposed to anthrax, though the agency has questions about its use in humans.
After a federal cigarette tax took effect in April and as the U.S. Food and Drug Administration's authority over the industry increases, tobacco companies are wary of the impact on their products and looking to cigarette alternatives such as smokeless tobacco for future growth.
GlaxoSmithKline PLC said Monday the Food and Drug Administration approved the seasonal flu vaccine Fluarix for children.
Amgen says the Food and Drug Administration wants more information about its osteoporosis treatment Prolia before granting marketing approval. It delays a drug seen as a potential blockbuster for the company.
It's official: Dodgers leaving Vero Beach by Dec. 31 The Dodgers' letter stated the termination of the lease agreement will take effect when another major league team takes possession of the facility or Dec. 31, whichever comes first.
Risking Kids to Sell FishLike small boats in an unending squall, U.S. consumers are buffeted from all sides with information about what kind of food to buy and why it's good -- or bad -- for them.
Deaths Associated with HPV Vaccine Start Rolling In, Over 3500 Adverse Affects ReportedAs Canada, in large part due to aggressive behind the scenes lobbying, rolls out the not-comprehensively-tested Merck HPV vaccine for girls as young as nine, a look at developments on the vaccine south of the border should cause Canadians serious concern.
Deadlines Are Piling Up in September For Must-Move LegislationAfter failing to meet several previous goals for going to conference on Food and Drug Administration overhaul bills, lawmakers in both chambers are committing to a new wrap-up date of Sept. 21.
Our girls are not guinea pigs - Is an upcoming mass inoculation of a generation unnecessary and potentially dangerous?...Emily's story is only one of 1,637 complaints involving Gardasil, filed as of May to the Vaccine Adverse Event Reporting System (VAERS), a national surveillance database sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC …
Pencils, Pens, MedsA discussion of the wanton prescribing of medication for America's Children who supposedly have ADHD.
China rejects unqualified pacemakers from USChina has returned 272 heart pacemakers imported from the United States after they failed quality inspections, China's top quality control agency announced on Monday.
FDA Warning On Codeine Use By Nursing MothersFDA Warning On Codeine Use By Nursing Mothers
A Consumer Guide for Avoiding Nano-SunscreensSun worshippers beware. While using sunscreen to block dangerous UV rays, you may be exposing yourself to a new danger.
Should You Get the HPV Vaccine?It's not recommended for everyone—find out if it's right for you.
Clinical Trial of BioGlue For Use In Cosmetic and Plastic SurgeryAn article about a new innovation in the wonderful world of plastic surgery.
China issues new regulation on food safety under pressure from home and broadChina's cabinet publicized a special regulation on the supervision of food safety on Friday amid serious criticism from home and abroad of the quality of food products made in China.
FDA urged to review sweetener's safety - Cancer - MSNBC.com - Mozilla FirefoxA U.S. consumer group called for an urgent Food and Drug Administration review of the safety of aspartame on Monday, but the FDA said there was no immediate need to do so despite a new study showing the sweetener may cause cancer.
Pharma pushes for faster drug approvalTwo top pharmaceuticals executives on Tuesday called on regulators to accelerate the approval of new medicines, claiming that intensifying demands for safety data were delaying patients access to them while providing no useful extra information.
Veggie foods recall is expandedThe U.S. Food and Drug Administration announced the expansion of a recall of food products produced by Robert's American Gourmet Food Inc.
The myth of a free market: America's health-care systemHealth-care regulation may act as a massive drag on the American economy - what one expert has called "a $169 billion hidden tax".
My Way News - US: Chinese Seafood Detained for SafetyWASHINGTON (AP) - Farmed seafood has now joined tires, toothpaste and toy trains on the list of tainted and defective products from China that could be hazardous to a person's health. Federal health officials said Thursday they were detaining three types of Chinese fish - catfis …
More Poison from China: Toxic Toothpaste Made in China Is Found in U.S.Consumers were advised yesterday to discard all toothpaste made in China after federal health officials said they found Chinese-made toothpaste containing a poison used in some antifreeze in three locations: Miami, the Port of Los Angeles and Puerto Rico.
China Blames Panama for Tainted ProductsChina acknowledged it was misleading for Chinese companies to label an industrial solvent as glycerin but blamed businesses in Panama for the poison turning up in cold medicine there, killing at least 51 people.
The Food and Drug Administration Has Blood on Its HandsCongressman Ron Paul (Texas), running for President these days, is more than an anti-war candidate; he has launched his campaign with the introduction of legislation in the House of Representatives that is likely to gain him plenty of recognition and unarguable public support.
FDA gets more powers over drug checksYears of scandal over unsafe medicines have led to beefed-up controls on newly approved drugs.
New survey lists hundreds of potential carcinogens The most comprehensive survey to date of environmental chemicals linked to breast cancer lists 216 compounds – many of which are commonly encountered in most women's lives.
Confessions of a WhistleblowerSome drugs are considered so dangerous—growth hormones, for instance—that Congress has put into play special laws that make it a felony to distribute them for purposes that the Food and Drug Administration hasn't approved.
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