FDA issues Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related violations tied to the...
Novo Nordisk reports favorable weight-loss data with its triple agonist UBT251 in a Phase 2 trial in China.
AdvaMed urges federal health officials to keep FDA at the center of oversight for artificial intelligence tools used in patient care, warning that new...
FDA issues a Warning Letter to A. Nelson & Co. Ltd., citing significant current good manufacturing practice violations and raising concerns about micr...
BioMarin decides to voluntarily withdraw from the market its Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with severe ...
Johnson & Johnson files a supplemental BLA seeking approval of Imaavy as a treatment for warm autoimmune hemolytic anemia.
FDA grants Immedica Pharma an accelerated approval for its BLA for Loargys (pegzilarginase-nbln), the first therapy specifically designed to lower pla...
FDA grants Array BioPharma a traditional approval for its previously accelerated-approved Braftovi (encorafenib) for use in combination regimens to tr...
