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Feasibility study and economic evaluation of HIV Pre-Exposure Prophylaxis

เชื้อไวรัสเอชไอวี (Human immunodeficiency Virus; HIV) เป็นเชื้อไวรัสที่สามารถติดจากเพศสัมพันธ์ ซึ่งนำไปสู่การเกิดโรคเอดส์ (Acquired Immune Deficiency Syndrome; AIDS) ส่งผลใ

FDA warns Hospira over Costa Rica infusion pump plant

The warning, stemming from an April inspection by U.S. regulators, does not restrict production or product shipments from the plant in La Aurora de Heredia, Costa Rica, Hospira said on Tuesday in a regulatory filing with the U.S. Securities and Exchange Commission.Among the issues cited by the FDA w

FDA warns Hershey over chocolate syrup labeling

In a warning letter to the company dated February 14, made public on Tuesday, the FDA said the labels on Hershey’s Syrup+Calcium and its Syrup Sugar Free with Vitamin & Mineral Fortification violate federal law.The FDA said the company may not use the terms “plus” and “fortification” on the labe

FDA warns Avon to smooth out claims on skin care products

From http://www.reuters.com/article/2012/10/17/us-fda-avon-idUSBRE89G00U20121017 In September, the regulator had warned L’Oreal SA for making similar claims. The FDA reviewed the company’s website in August, and objected to claims made about the products Anew Clinical Advanced Wrinkle Corrector, Ane

FDA warns against use of Pfizer’s Revatio in children

While the drug has never been approved for treatment of PAH in children, the U.S. Food and Drug Administration’s warning is against off-label use of the drug.Revatio, which has the same active ingredient as Pfizer’s erectile dysfunction drug Viagra, is used to improve the ability to exercise in peop

FDA rejects expanded use of Regeneron drug for gout

The rejection follows a unanimous vote against the drug’s approval in early May by advisors to the U.S. Food and Drug Administration, with panel members expressing concern that the company had only done a 16-week study.The agency has requested additional clinical data, including chemistry, manufactu

FDA approves Ironwood constipation drug

The drug, linaclotide, will be sold under the brand name Linzess and carry a boxed warning that it should not be used in patients 16 or younger, the agency said.An estimated 63 million people suffer from chronic constipation, according to the National Institutes of Health. Additionally, an estimated

FDA approves Amgen’s Prolia for new use

People suffering from osteoporosis experience severe weakening and thinning of bones.Prolia currently has U.S. approval to treat postmenopausal women with osteoporosis at high risk for fracture. The drug brought in sales of $120 million to Amgen between April and June, up 36 percent sequentially.Acc

FDA advisers back wider use of Abbott’s Humira

(Reuters) – Abbott Laboratories Inc won a U.S. panel’s support on Tuesday for wider use of its blockbuster rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.A panel of outside advisers to the Food and Drug Administration voted 15 to 2 that the benefits of Humira ou
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