The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, […]
The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum […]
U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction on Sept. 25, 2015, against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility […]
The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.
The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.
The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical […]
The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
Today the U.S. Food and Drug Administration issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products – including its Camel Crush Bold brand – because the company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic […]
Today, the U.S. Food and Drug Administration approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.
The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.
The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.
Today the U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as “additive-free” and/or “natural.” The warning letters are for violations of section 911 of the Federal Food, […]
The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP […]
The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
Today, U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the […]
Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.