Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...
A proposed ban on formaldehyde in chemical hair straightening products—linked to cancer and other health risks—has hit a ...
Red 3—also called FD&C Red No. 3, erythrosine or E127—has been widely used in food, cosmetics and pharmaceuticals since its ...
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the ...
Drug firm Laurus Labs Ltd on Wednesday (January 22) said its wholly-owned foreign subsidiary Laurus Generics Inc (LGI), based in Berkeley Heights, New Jersey, has received a Form 483 from the US Food ...