July 16, 2014

RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications. 

July 14, 2014

Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.

July 11, 2014

Anacor Pharmaceuticals announced that the Food and Drug Administration has approved the company's new drug application for Kerydin (tavaborole) topical solution, 5% — an antifungal approved for the topical treatment of onychomycosis of the toenails.

July 10, 2014

The Food and Drug Administration in late June issued a warning letter to Zarbee's for making therapeutic claims regarding a dietary supplement product.

July 10, 2014

The Food and Drug Administration on Wednesday shut down a company for noncompliance of the dietary supplement current good manufacturing practice requirements. 

July 10, 2014

A wave of new drug introductions and healthcare policy changes has had a significant impact on women’s health care over the past year.

July 10, 2014

A survey co-released 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.

July 8, 2014

Attendees will have the opportunity to learn directly from the FDA about the implications of the Drug Supply Chain Security Act of 2014.

July 8, 2014

NeuroMetrix on Tuesday announced that its wearable technology for treatment of chronic pain received 510(k) clearance from the Food and Drug Administration for over-the-counter use.

July 8, 2014

Purdue Pharma on Tuesday announced that the Food and Drug Administration has granted priority review designation for the company's once-daily, single-entity hydrocodone bitartrate tablet. 

July 7, 2014

Novo Nordisk on Monday announced that the Food and Drug Administration approved the company's NovoSeven RT (coagulation factor VIIa [recombinant]).

July 7, 2014

Depilatory brand Veet has announced the launch of its new Veet Infini'Silk line — the brand's first Pulsed Light FDA-cleared permanent hair reduction devices.

July 3, 2014

The Food and Drug Administration on Thursday announced approval for Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma.

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

On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.

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 30, 2014

Afrezza, an inhaled insulin powder meant to treat diabetes patients, was approved Friday by the Food and Drug Administration.

June 27, 2014

The Food and Drug Administration on Thursday notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.

June 27, 2014

Ohm Labs, a wholly owned subsidiary of Ranbaxy Labs, on Friday announced that it received approval from the Food and Drug Administration to manufacture and market valsartan tablets in 40 mg, 80 mg, 160 mg and 320 mg dosage strengths.

June 26, 2014

The Acetaminophen Awareness Coalition on Thursday released “Acetaminophen: How It’s Used, Preventing Overdose and What We Can Do to Promote Safe Use,” a report and educational resource to drive safe and appropriate use of one of the United States’ most common drug ingredients.

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.