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

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

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

(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

Factors Affecting Health-Care Costs and Hospitalizations among Diabetic Patients in Thai Public Hospitals. Chaikledkaew U1,2, Pongchareonsuk P1, Chaiyakunapruk N3,4,5, Ongphiphadhanakul B6. 1Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok,Thailand; 2Health Interventio

A substance in human breast milk seems to reduce the risk of mother-to-child transmission of H.I.V., scientists have reported.Researchers working in Zambia collected breast milk samples from 81 H.I.V.-positive women who transmitted the virus to their infants during breast-feeding, 86 H.I.V.-positive

The Food and Drug Administration has agreed to give priority status to its review of three new uses for the anticlotting drug Xarelto, Johnson & Johnson announced Monday.The company is asking the agency to approve the drug to treat deep vein thrombosis and pulmonary embolism, and to prevent recu

New drugs for breast cancer and multiple myeloma won approval from the Food and Drug Administration on Friday, expanding options for patients in advanced stages of those diseases.The breast cancer drug, Afinitor from Novartis, seems to expand the time that endocrine therapy can keep the disease in c

The world is rapidly changing. In mid-2023, NASA found that the average temperature in the Northern Hemisphere was the highest in 170 years, with ice melting 6-7 times faster compared to 25 years ago. Antonio Guterres, the Secretary-General of the United Nations (UN), announced