Regulatory Affairs Syndicator

Austin American-Statesman - After several years of delay, the Food and Drug Administration said Monday that it was moving toward endorsing sale of the morning-after pill without a prescription for women 18 and older, signaling what may be the end of one of the most …

FDA recently approved two new vaccines manufactured by Merck and Co. The first one, called Gardasil, prevents cervical cancer, precancerous genital lesions and genital warts caused by human papillomavirus (HPV).

Gardasil is effective against four…

FDA recently approved a new drug to treat Parkinson’s disease, called Azilect (rasagiline). Azilect is an MAO type-B inhibitor that blocks the breakdown of dopamine in the brain. Azilect was approved as a single therapy for treating early Parkinson…

A recent study in the New England Journal of Medicine suggests that ACE inhibitors, which are widely used to treat hypertension, may be associated with an increased risk of major congenital malformations when used by women during the first trimester …

FDA has learned of a rare, possibly fatal disease among patients with renal failure who underwent Magnetic Resonance Angiography (MRA) using Omniscan, a contrast agent containing gadolinium. The disease is called Nephrogenic Systemic Fibrosis/ Nephr…

A recent FDA article describes severe pain associated with two bisphosphonate drugs: Fosamax (alendronate sodium) and Actonel (risedronate sodium).

The article, which was published in the Archives of Internal Medicine, describes over a hundred r…

In a previous show, we told you about a report from the Institute for Safe Medication Practices (ISMP) which warned about inadvertently giving neuromuscular blocking agents such as pancuronium to patients who aren’t receiving ventilator support. Thi…

Splitting tablets is a common practice where tablets of a higher strength than the patient needs are broken in half, or even quarters, to provide the correct dose. This is often done to reduce costs, since the higher strength tablet sometimes costs …

A new Chinese medicine for treating lung cancer officially entered the market on Sunday, promising new hope for patients, researchers said.

FDA Contemplates Over-the-Counter 'Plan B' Drug SalesTechNewsWorld, CA - 20 minutes agoThe Food and Drug Administration may consider allowing sales of the so-called morning-after pill without a prescription. So far …

XinhuaNew Chinese medicine promises hope for lung cancerXinhua, China - 3 hours agoAfter clinical trials on hundreds of patients, the new drug, approved by the State Food and Drug Administration (SFDA), had proved to be more effective than …

WKYT 27 - MONDAY, June 5 (HealthDay News) — Setting strict guidelines as a condition, the U.S. Food and Drug Administration said Monday that it will allow the return of the multiple sclerosis drug Tysabri. Tysabri (natalizumab) had received FDA approval in …

WKYT 27 - (HealthDay News) — As the cost of prescription drugs continues to soar, patients and doctors alike are turning to generic alternatives. But are they the same? Yes, says the U.S. Food and Drug Administration. Generics are chemically identical to …

Journal issues caution about study on breast implants and platinum WASHINGTON, Aug.

FDA OKs trial of Ono Pharm/Medarex cancer drug-OnoReuters - 11 hours ago… (MEDX.O: Quote, Profile, Research) has received approval from the US Food and Drug Administration to conduct clinical trails of their experimental cancer drug … Mederax…