January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

January 16, 2014

The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

January 13, 2014

The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

January 10, 2014

The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

January 2, 2014

The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.

December 30, 2013

The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

December 26, 2013

The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

December 26, 2013

Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

December 26, 2013

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years.

December 23, 2013

The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

December 23, 2013

The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

December 18, 2013

The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

December 18, 2013

The Food and Drug Administration has approved a new drug made by GlaxoSmithKline and Theravance for treating chronic obstructive pulmonary disease, the agency said Wednesday.

December 16, 2013

A drug made by Novartis extends the lives of patients with a life-threatening blood cancer to a greater extent than conventional therapy or placebo, according to results of a late-stage clinical trial.

December 13, 2013

Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

December 12, 2013

A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.

December 11, 2013

The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said.

December 10, 2013

NEW YORK — Absorption Pharmaceuticals will be conducting clinical trials with Kaiser to measure the efficacy of the company's over-the-counter solution for PE Promescent, CNBC reported Tuesday.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

December 5, 2013

Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.

December 4, 2013

The Food and Drug Administration has approved a new topical drug for treating scars made by Oculus Innovative Sciences, the drug maker said Wednesday.