FDA publishes a draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Drug Development Programs for Treatment.
Roche/Genentech make suggestions for clarification and improvement to an FDA draft guidance on developing treatments for neovascular age-related macul...
CDRH asks for public comment on eight questions about using medical technologies in a home setting.
A New Jersey oncologist becomes the third doctor to plead guilty to participating in a scheme to purchase prescription oncology drugs under false pret...
FDA clears an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality.
CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a partner resident.
Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they informed the agency that the products were no longe...
FDA approves Pfizers Abrysvo vaccine to prevent respiratory syncytial virus in older adults.
