February 13, 2014

After meeting for two days earlier this week, the Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-9 against changing the label of naproxen to highlight a lower cardiovascular risk profile as compared to other NSAIDs, according to published reports.

February 13, 2014

Janssen Biotech announced that the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy.

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

February 12, 2014

America’s biopharmaceutical research companies currently are developing 180 new medicines to help the nearly 400 million people who have diabetes worldwide, the Pharmaceutical Research and Manufacturers of America announced Tuesday.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

February 11, 2014

Multicultural cosmetics brand Milani has hit the ground running this year with a new leadership team, a re-energized brand platform and marketing and communications plans to enter its next evolution in business in 2014.

February 10, 2014

AliveCor announced that the Food and Drug Administration has granted the company over-the-counter clearance for the AliveCor Heart Monitor, a single-channel ECG (electrocardiogram) recorder, previously available by prescription only.

February 7, 2014

A new and possibly transformative technology for rapidly diagnosing and evaluating patients based on their specific genetic profile may soon begin appearing at retail pharmacies and clinics, giving pharmacists and clinicians another tool for advancing patient health outcomes and their own practice capabilities.

February 6, 2014

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

February 6, 2014

The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.

February 4, 2014

The Food and Drug Administration on Tuesday unveiled its first youth tobacco prevention program, “The Real Cost,” which will target at-risk youth ages 12 to 17 who are open to smoking or already experimenting with cigarettes.

February 4, 2014

Salix Pharmaceuticals announced that the Food and Drug Administration has accepted for filing a new drug application for Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.

February 3, 2014

The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday.

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

January 31, 2014

Valeant Pharmaceuticals International announced that it received approval from the Food and Drug Administration for Retin-A Micro (tretinoin) gel microsphere 0.08%.

January 30, 2014

Novartis Consumer Health will be relaunching Theraflu for the 2014-2015 cough-cold season, Brian McNamara, Novartis division head OTC, told analysts.

January 29, 2014

A pair of Food and Drug Administration advisory committees will be meeting Feb. 10 to talk about heart risks associated with use of NSAIDs and whether or not Bayer's Aleve (naproxen) carries a lower risk profile than other NSAIDs

January 29, 2014

Teva announced that the Food and Drug Administration approved its supplemental new drug application for three-times-a-week Copaxone in 40mg/mL form.

January 28, 2014

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

January 27, 2014

The Food and Drug Administration will hold a public meeting of the Allergenic Products Advisory Committee on Tuesday to determine the safety and efficacy of Ragwitek, a short ragweed pollen allergen extract tablet for sublingual use.

January 27, 2014

Walgreens Infusion Services on Monday announced that it has been selected as the preferred provider of home administration services for Makena (hydroxyprogesterone caproate injection), the only FDA-approved medication to help reduce the risk of preterm birth for clinically indicated patients.

January 24, 2014

Hi-Tech Pharmacal Co., a specialty pharmaceuticals company, announced that it was granted final approval from the Food and Drug Administration for bromfenac ophthalmic solution 0.09% (once-a-day).

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.