The FDA on Wednesday approved Bayer HealthCare's Xofigo injection for advanced prostate cancer, three months ahead of schedule. Xofigo had a priority review status with a decision date of Aug. 14, 2013.
Theravance Inc. (THRX) and GlaxoSmithKline Plc (GSK, GSK.L) said Friday the U.S. Food and Drug Administration has approved Breo Ellipta for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD. The FDA also approved the...
Warner Chilcott plc (WCRX) Thursday announced the United States Food and Drug Administration or FDA approval of a new oral contraceptive, norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets, for the prevention of pregnancy. The product does not currently have a brand...
A bronzed or tanned skin is many a fashionista's first choice. People pursue tanning outdoors by relaxing in the sun, or indoors using sunlamp products like tanning beds and tanning booths. Although some believe that tanning indoors is safer than tanning in the sun, this is not true.
Merck & Co. Inc. (MRK) Friday announced the U.S. Food and Drug Administration's approval of LIPTRUZET tablets for the treatment of elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia, as adjunctive therapy to diet, when diet alone is not enough.
LIPTRUZET...
AVEO Pharmaceuticals Inc. (AVEO), doing business as AVEO Oncology, said Thursday a committee of the U.S. Food and Drug Administration rejected its investigational agent tivozanib to treat advanced renal cell carcinoma as the drug failed to show a favorable benefit-to-risk evaluation in affected patients.
Shares...
Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), said Tuesday that the U.S. Food and Drug Administration has approved the emergency contraceptive Plan B One-Step tablet 1.5 mg for over-the-counter sale to consumers 15 years of age and older in the United...
Raptor Pharmaceutical Corp. (RPTP), on Tuesday said that the U.S. Food and Drug Administration or FDA has approved PROCYSBI, the company's drug for the treatment of nephropathic cystinosis in adults and children.
The company in a statement added that the Phase 3 study of PROCYSBI revealed sucessful...
The U.S. Food and Drug Administration Monday approved Kcentra or Prothrombin Complex Concentrate, Human, for the urgent reversal of vitamin K antagonist or VKA anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.
Gilead Sciences Inc. (GILD) said Monday the U.S. Food and Drug Administration has rejected its New Drug Applications for two HIV drugs, elvitegravir and cobicistat.
citing recent inspections, the FDA in its Complete Response Letters said deficiencies in documentation and validation of certain quality...
Malaria, caused by a parasite called Plasmodium, which is spread to humans through the bite of an infected female Anopheles mosquito, is a major global public health challenge. One of the critical issues in malaria is tackling the problem of counterfeit or substandard drugs.
Warner Chilcott plc (WCRX), On Monday revealed that the United States Food and Drug Administration or FDA has approved the company's contaceptive MINASTRINTM 24 FE.
The company in a statement added that the drug was manufactured by a third party and also that it does not expect to be in a position...