FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to delay the onset of stage...
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of ...
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.
FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys production of injectable we...
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standa...
FDA warns the University of California at San Francisco radiopharmaceutical facility about CGMP violations in its production of finished drugs.
FDA warns Par USA/Endo USA about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or deceptive statements ...
