February 17, 2011

Savient Pharmaceuticals announced changes to its management team as it gears up for the commercial launch of its chronic gout treatment.

February 15, 2011

Mylan has launched a generic drug for fungal infections, the company said Tuesday.

February 14, 2011

GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

February 14, 2011

The Food and Drug Administration has accepted for review an application for a pain medication designed to thwart drug abusers.

February 14, 2011

Gilead Sciences has refiled an approval application with the Food and Drug Administration for an HIV drug, the drug maker said.

February 11, 2011

The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.

February 11, 2011

The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

February 11, 2011

Genentech, a subsidiary of Roche, reported that its eye drug helped improve vision in patients suffering from a complication caused by diabetes.

February 11, 2011

The Food and Drug Administration has approved a drug for preventing preterm births.

February 11, 2011

The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

February 11, 2011

Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

February 10, 2011

Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

February 10, 2011

This year’s upcoming $29 billion wave of margin-friendly generic pharmaceuticals will be as big a growth catalyst for supermarket pharmacies as it will be for their pureplay drug store cousins, Credit Suisse research analyst Ed Kelly stated in a note published Thursday.

February 10, 2011

The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.

February 8, 2011

The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising claims made by Iceberg Labs for its Immune Shield dietary supplement to the Federal Trade Commission and Food and Drug Administration for further review.

February 8, 2011

The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

February 7, 2011

The Food and Drug Administration has approved a generic cancer drug from Hospira.

February 4, 2011

The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

February 4, 2011

A private entrepreneur is close to introducing a take-home intracervical insemination fertilization kit to retail, according to a story published in the Pittsburgh Post-Gazette Friday.

February 4, 2011

The Food and Drug Administration has approved a generic Alzheimer’s disease treatment from Sun Pharmaceutical Industries.

February 2, 2011

The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

February 2, 2011

One of the more recognizable faces of the Natural Products Association will be leaving association work in favor of the Food and Drug Administration, Drug Store News learned Wednesday.

February 1, 2011

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


February 1, 2011

Thanks to technological innovations within mascara, the category has driven sales of eye makeup, and looking forward, mascara formulas that are infused with eyelash-enhancing treatments and packaging that offers greater customization not only will volumize lashes but also sales at retail.