Both companies had already received the go-ahead months earlier from the U.S. Food and Drug Administration, which said each company’s lab-grown chicken is safe for human consumption.
The Food and Drug Administration on Friday announced its intention to start regulating tests developed in laboratories — closing the “Theranos loophole” that has allowed inaccurate tests to ...
The decision paves the way for San Francisco-based startup Eat Just to sell lab-grown chicken meat. The meat will initially be used in nuggets, but the company hasn’t said when they will become ...
WASHINGTON — The Food and Drug Administration on Friday laid out a proposal to begin regulating laboratory medical tests, a multibillion-dollar industry that the agency says poses a growing risk ...
The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug's manufacturer, announced today. It is the first tocilizumab biosimilar ...
The US Food and Drug Administration is proposing to step up its oversight of a growing category of medical tests called laboratory-developed tests. The FDA approves and clears many types of lab ...
FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE ...
Austrian shoppers will be noticing a new fish in their grocer's freezer, one that's never once been in the water. And consumers in the United States will be getting their chance to try it by 2025.
Laboratory-developed tests have long skirted FDA oversight, though the agency has always maintained that it has the authority to step in. Debate over regulating the space stretches back to the ...
(RTTNews) - Biogen Inc. (BIIB) announced that the U.S. Food and Drug Administration has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ...
The U.S. Food and Drug Administration (FDA) on Thursday approved the medication Exxua to treat major depressive disorder – a significant step after a decades-long battle for approval. Exxua is ...
(RTTNews) - Biogen Inc. (BIIB) announced that the U.S. Food and Drug Administration has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ...
