Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that they were no longer marketed.
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
FDA clears a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System an implant that adapts to the joint's anatomy during insertion to offer increas...
FDA clears a Phonak 510(k) for its Phonak Lyric hearing aid and a self-replacement option to reduce office visits.
Federal Register notice: FDA makes available a veterinary-use draft guidance entitled #290 (VICH GL61) Pharmaceutical Development.
An unusually strident Wall Street Journal editorial apologizes to its readers for supporting FDA commissioner Robert Califfs appointment now that hes ...
Regeneron faces a potential approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patien...
A just-introduced bill, Fixing Administrations Unethical Corrupt Influence Act, restricts top federal health officials at FDA, CDC and NIH from cashin...
