April 7, 2015

A new indication for Boehringer Ingelheim Pharmaceuticals's Pradaxa may be on the horizon. 

April 7, 2015

Harvard researcher on Tuesday reported that BMPEA, an amphetamine isomer, was found in supplements containing the ingredient Acacia rigidula. 

April 3, 2015

The New York Attorney General on Thursday joins forces with 14 AGs from across the country.

April 2, 2015

Alere's i Strep A test received marketing clearance from the Food and Drug Administration on Thursday. 

April 1, 2015

The recently Food and Drug Administration-approved AirStrip Sense4Baby monitoring system will enable remote self-administered non-stress tests as part of a comprehensive prenatal care model. 

April 1, 2015

Following a recent warning against the use of homeopathic asthma remedies, the agency is holding a meeting to evaluate homeopathic remedies as a class of medicines. 

April 1, 2015

Teva said it expects the product to be available to patients during second-quarter 2015.

March 31, 2015

The director of the FDA’s Office of Generic Drugs temporarily steps down to deal with a medical issue, according to a report by the Regulatory Focus Professionals Society.

March 30, 2015

The supplement industry criticized the agreement between GNC and the New York Attorney General's office. 

March 30, 2015

GNC on Monday announced an agreement with the New York Attorney General's office affirming that all of the products called into question by the office were actually in full compliance with cGMPs. 

March 27, 2015

The Food and Drug Adminisration on Friday revisited the issue of supplemental applications proposing labeling changes for approved drugs and biologic products. 

March 26, 2015

The Council for Responsible Nutrition on Thursday called on its members not to market powdered pure caffeine to consumers in support of FDA efforts.

March 23, 2015

The Food and Drug Administration last week warned consumers against using homeoapthic asthma remedies. 

March 23, 2015

Acura Pharmaceutical's Nexafed extended release demonstrated bioequivalence to Sudafed 12-hour tablets. 

March 19, 2015

In a letter to the Senate, the Food and Drug Administration acknowledged that DNA barcoding is not routinely used to identify botanical ingredients. 

March 13, 2015

Actavis on Friday announced that the Food and Drug Administration approved Saphris for the treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients.

March 11, 2015

A coalition of state attorneys general is organized by New York Attorney General Eric Schneiderman to investigate herbal supplements. 


March 10, 2015

The Food and Drug Administration recently published bio-equivalence guidance documents. 

March 9, 2015

DSN examines chain pharmacy, including in-depth coverage of provider status, kiosks, Medicare and the GPhA elections, in this multi-page report.

March 6, 2015

The Food and Drug Administration approved Zarxio, making it the first approved biosimilar product in the United States.

March 4, 2015

DexCom received Food and Drug Administration approval for its Dexcom G4 Platinum Continuous Glucose Monitor System with Share. The Share receiver uses a wireless connection via Bluetooth Low Energy between the patient’s receiver and an app on the patient’s smartphone to relay glucose information to apps on the mobile devices of up to five designated recipients, or “followers.”


March 2, 2015

The FDA is expected to issue new guidance on biosimilars labeling and generic opioids before the end of year, according to a report by the Regulatory Affairs Professional Society.

February 26, 2015

Congress introdues legislation to protect FDA user fees from sequestration. 

February 26, 2015

The fixed-combination drug Avycaz was granted priority review by the Food and Drug Administration.