FDA commissioner Martin Makary says he wants to find ways to get drugs to consumers faster, but also find ways to reduce the need for drugs by address...
Newly appointed CBER director Vinay Prasad abruptly leaves the agency after being attacked by Trump influencer Laura Loomer for expressing purportedly...
FDA grants Calidi Biotherapeutics fast-track status for CLD-201, an allogeneic stem-cell-loaded oncolytic virus being developed to treat soft tissue s...
FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medical device specificati...
FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.
Johnson & Johnson files a supplemental BLA seeking to update the prescribing information for Tremfya (guselkumab) to include new data demonstrating it...
FDA recommends placing 7-hydroxymitragynine (7-OH) a highly concentrated, synthetic byproduct of the kratom plant under the Controlled Substances Act...
FDA warns Indias Shiva Analyticals Private Limited about CGMP violations in its work as a contract testing laboratory.
