Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) will hold a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting in connection with its review of the pending New Drug Application (NDA) for Brinavess™ (vernakalant hydrochloride, IV).
As FDA deadlines approach for regulations on electronic tobacco products, observers say the industry is in for a period of change and consolidation.
The U.S. Food and Drug Administration (FDA) issued 13 warning letters in October that were sent to manufacturers and other companies found to have violated FDA regulations.
To conduct in vitro testing of the effects of excipients on oral drug absorption
Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.
Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA requested VOYAGER top-line data to inform its review of fourth-line GIST indicatio
For nearly 20 years, regenerative medicine such as cell and gene therapies have gradually shown much promise in repairing or replacing damaged and infected cells, tissues and organs in order to cure ailments including organ failure, spinal cord injuries, multiple sclerosis and other traumatic wounds and diseases.
Legal teams pursuing numerous lawsuits against Johnson & Johnson on behalf of ovarian cancer victims alleging that asbestos in the manufacturer's baby powder made them sick are saying that J&J's announcement Friday of a voluntary recall of the product should help prove their claims.
PhaeoSOL is a natural microalgae-based nutritional ingredient aiming at improving the well-being of the elderly and preventing certain metabolic disorders
The U.S. Food and Drug Administration recalled 28 animal products from January through September of 2019, the agency reported.
Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it received 510K regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral feeding device.
U.S. Sen. Richard Blumenthal (D-CT) recently held a press conference in which he pleaded with the U.S. Food and Drug Administration (FDA) to establish a regulatory framework for the safe use of CBD.
Over the next four years, the U.S. Food and Drug Administration (FDA) will be providing more than $15 million to 12 new clinical trials. The grants will help enhance the development of medical products for patients with rare diseases – mainly those affecting children.
Company Settles Legal Action Resulting in Outright Ownership of the Drug
The U.S. Food and Drug Administration (FDA) recently unveiled a series of guidances about utilizing digital health tools to help patients.
According to an article on the Forbes website, vaping will impact two sectors of the financial markets the most: Big Tobacco and marijuana stocks.
The U.S. Food and Drug Administration issued 19 warning letters in September that were sent to manufacturers and other companies found to have violated FDA regulations.