March 26, 2012

Sunpeaks Ventures last week announced national advertising support behind its Clotamin multivitamin line — a line of supplements formulated for use by patients on warfarin or other blood thinners.

March 22, 2012

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

March 22, 2012

GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

March 19, 2012

The Food and Drug Administration has approved the first generic version of a drug for treating and preventing osteoporosis in women after menopause, the agency said Monday.

March 8, 2012

The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

March 1, 2012

The Food and Drug Administration has approved what it called the first flu vaccine to prevent four strains of the influenza virus.

March 1, 2012

The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

February 28, 2012

The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

February 28, 2012

Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

February 23, 2012

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

February 21, 2012

An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

February 15, 2012

Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

February 9, 2012

The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

February 9, 2012

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

February 1, 2012

The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

January 31, 2012

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

January 30, 2012

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

January 27, 2012

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

January 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

January 3, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

December 23, 2011

The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants.

December 21, 2011

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

December 19, 2011

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

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.