October 8, 2013

The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

October 4, 2013

A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

October 1, 2013

The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

September 30, 2013

The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

September 23, 2013

The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

September 23, 2013

The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

September 19, 2013

A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

September 19, 2013

Inovalon and Walgreens on Thursday announced that they have entered into a multi-year agreement to provide Inovalon's data-driven encounter support platform, Electronic Patient Assessment Solution Suite (ePASS) within Healthcare Clinic at select Walgreens to support improvements in managed care quality and performance.

September 17, 2013

The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

September 10, 2013

The country's embryonic biosimilars industry scored a victory last month as the organization that runs the pension fund for California state employees announced its opposition to a state Senate bill provision that would impose special requirements on pharmacists who dispense follow-on biologics.

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

September 10, 2013

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

September 10, 2013

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff.

September 5, 2013

Japanese drug maker Otsuka Pharmaceutical Co. is buying U.S.-based Astex Pharmaceuticals for $886 million, Otsuka said Thursday.

September 3, 2013

The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.

September 3, 2013

Sage North America last week announced that it partnered with McKesson Pharmacy Systems & Automation, a division of McKesson, to help develop the McKesson Mobile Delivery application for prescription delivery services.