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 30, 2012

Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.

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 27, 2012

The New England Journal of Medicine on Thursday published an op-ed online that called for more rule-making to govern dietary supplements in an effort to rein in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.

January 27, 2012

Mead Johnson Nutrition CEO Stephen Golsby on Thursday announced that the company will be deploying a significant ad campaign to recapture any lost trust among moms because of an Enfamil "pull-and-hold" in December.

January 27, 2012

Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

January 26, 2012

A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

January 25, 2012

The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

January 25, 2012

Johnson & Johnson is preparing to turn the corner with its McNeil Consumer Healthcare business, J&J chairman and CEO William Weldon told analysts during the company's fourth-quarter earnings call Tuesday.

January 25, 2012

Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.

January 24, 2012

The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.

January 24, 2012

The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.

January 23, 2012

A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

January 23, 2012

Perrigo is seeking approval from the Food and Drug Administration for a drug used to treat allergies in adolescents and adults, the company said Monday.

January 23, 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.

January 20, 2012

One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs.

January 20, 2012

One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

January 20, 2012

It has become a perennial issue, and one that is likely to crop up at least once this year: patent settlements.


January 20, 2012

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


January 20, 2012

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

January 19, 2012

The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

January 19, 2012

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

January 19, 2012

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 18, 2012

The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.