July 3, 2014

The Food and Drug Administration on Tuesday made available a draft of its strategic priorities over the next four years for public comment.

July 3, 2014

As the healthcare landscape continues to change at a rapid pace, the National Association of Chain Drug Stores is supporting a bipartisan initiative aimed at accelerating the pace of cures and medical breakthroughs in the United States.

July 2, 2014

The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013. 

July 2, 2014

As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.

June 26, 2014

The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

June 25, 2014

Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.

June 25, 2014

Pharmacists in Pennsylvania may soon be required to notify physicians prior to substituing a biologic medicine with a biosimilar medication following the passing of a bill by the Pennsylvania Senate, the Associated Press reported Tuesday.

June 23, 2014

The Food and Drug Administration announced that it has approved Sivextro (tedizolid phosphate), an antibacterial drug.

June 18, 2014

A survey co-released Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.

June 17, 2014

Novartis on Tuesday announced that it had submitted a biologic license application to the Food and Drug Administration for marketing approval for the use of Bexsero.

June 12, 2014

Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.

June 11, 2014

Strativa Pharmaceutical, a division of Par Pharmaceutical Cos., announced that the Food and Drug Administration approved Nascobal, a prescription B-12 supplement administered once a week as one spray.

June 10, 2014

The Food and Drug Administration last week published an interim final rule to further safeguard the health of infants fed infant formula in the United States.

June 9, 2014

BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII).

June 9, 2014

A recently approved drug might make infusions for hemophiliacs fewer and further between. The Food and Drug Administration approved Biogen Idec's Eloctate, which clinical trials have shown works to treat bleeding episodes and to increase the time between prophylactic blood infusions for those with hemophilia A.

June 3, 2014

Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.

June 2, 2014

Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.

May 30, 2014

Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.

May 29, 2014

Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155.

May 23, 2014

The Food and Drug Administration on Friday approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin and skin structure infections.

May 23, 2014

Teva Pharmaceutical on Friday announced that the Food and Drug Administration approved the use of QVAR (beclomethasone dipropionate HFA) with a dose counter for the treatment of asthma in patients 5 years of age and older.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 15, 2014

The stampede of big-selling branded medicines that hurtled off the patent cliff in 2011 and 2012 has slowed to a relative trickle.

May 14, 2014

The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.