The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two ...
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
Gilead's (GILD.O), opens new tab Trodelvy also belongs to the same class of drugs. AstraZeneca and Daiichi's first co-developed ADC, Enhertu, was first approved by the FDA in 2019 for a type of ...
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
The US Food and Drug Administration (FDA) has expanded the approval for Johnson & Johnson’s nasal spray Spravato to allow its ...
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...
The newly FDA-approved nasal spray called Spravato is being manufactured by Johnson & Johnson's and is a standalone treatment ...