July 5, 2012

The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

July 2, 2012

Bristol-Myers Squibb is acquiring Amylin Pharmaceuticals, the drug maker said Friday.

June 29, 2012

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.

June 29, 2012

The Food and Drug Administration has granted priority review for an investigational cancer treatment created by Bayer and Onyx Pharmaceuticals.

June 29, 2012

Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.

June 28, 2012

The Supreme Court on Thursday identified the Patient Protection and Affordable Care Act as a tax, which means the constitutionality of the healthcare-reform package cannot be addressed until after that tax is assessed.

June 28, 2012

A new continuing-education program offered by a national pharmacist professional organization aims to prepare pharmacists to communicate with patients about the safe and effective use of the painkiller acetaminophen.

June 28, 2012

The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

June 28, 2012

A drug maker and a branch of the National Education Association have released a set of education resources designed to curb prescription drug abuse and misuse.

June 28, 2012

While the Supreme Court on Thursday morning left the Patient Protection and Affordable Care Act mostly intact, the court did rule that Congress cannot withhold federal Medicaid spending from a state that does not expand its eligibility requirements under the act.

June 27, 2012

The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

June 26, 2012

The Food and Drug Administration has approved a new Daiichi Sankyo manufacturing center that the company said would strengthen its domestic and global supply chain.

June 26, 2012

The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.

June 25, 2012

The U.S. pharmaceutical subsidiary of Eisai has promoted one of its executives.

June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

June 22, 2012

The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

June 21, 2012

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention.

June 21, 2012

While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like. 


June 21, 2012

The Food and Drug Administration has approved a new indication for a Pfizer drug.

June 21, 2012

Drug Store News recently talked with COPD Foundation founder and president John Walsh about the organization’s new leadership. In March, the COPD Foundation took over leadership for Drive4COPD, which aims to screen people for chronic obstructive pulmonary disease, a collective term for emphysema and chronic bronchitis, which the group estimates to affect 24 million Americans who may have it but don’t know it.


June 21, 2012

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

June 21, 2012

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.

June 21, 2012

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


June 21, 2012

Specialty and biologically engineered medicines have been a boon to millions of Americans with life-threatening and life-altering conditions. But their lofty prices are squeezing patients and payers and spawning a growing legislative backlash that threatens insurers and employer-based health plans.