On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With ...
FDA officials said an agency review of the available data found oral phenylephrine is not effective as a nasal decongestant ...
The U.S. Food and Drug Administration has proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an ...
NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.
The US Food and Drug Administration (FDA) has proposed an order to ban a popular ingredient in cold and flu medicines as it is seemingly not as effective as other methods. Oral phenylephrine is often ...
 At the conclusion of the May 13-16 inspection of the firm’s LACF facility, FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations. Key issues included failure to ...
The Food and Drug Administration will allow a new device to be marketed as a treatment for dry age-related macular degeneration.
Novo Nordisk landed in hot water with the FDA following an inspection at one of the drugmaker’s key semaglutide and insulin manufacturing plants this past spring. The regulatory reprimand ...
Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...
On Thursday, November 7, the FDA categorized this recall as a Class II, meaning: "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse ...