December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

December 21, 2011

Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

December 20, 2011

The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.

December 19, 2011

The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

December 19, 2011

The Food and Drug Administration has approved a drug made by Sandoz for treating yeast and other fungal infections.

December 16, 2011

ViroPharma has received approval for updated labeling to its antibiotic drug.

December 15, 2011

A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

December 15, 2011

The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.

December 14, 2011

A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

December 12, 2011

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

December 12, 2011

The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

December 12, 2011

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

December 9, 2011

The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

December 9, 2011

"I am appalled that politics has once again trumped science," wrote Brooklyn College Health Clinic director and nurse practitioner Ilene Tannenbaum in a letter to the New York Times. That reaction summed up much of the medical community's response to the Department of Health and Human Services' overruling of the Food and Drug Administration's decision to make the Plan B contraceptive pill a full nonprescription product.

December 8, 2011

A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

December 8, 2011

According to a report published Wednesday on the site of MobiHealthNews, the Food and Drug Administration has approved an iPhone glucose meter called AgaMatrix Nugget from Sanofi.

December 7, 2011

Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration's draft guidance regarding new dietary ingredient reporting requirements.

December 7, 2011

A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

December 7, 2011

Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

December 7, 2011

At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

December 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

December 7, 2011

The Department of Health and Human Services on Wednesday denied a request made by Teva Pharmaceuticals to relax merchandising restrictions for the emergency contraceptive Plan B.