[ Price : $8.95]
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.[ Price : $8.95]
FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys product...[ Price : $8.95]
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in com...[ Price : $8.95]
FDA warns the University of California at San Francisco radiopharmaceutical facility about CGMP violations in its production of fi...[ Price : $8.95]
FDA warns Par USA/Endo USA about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or d...[ Price : $8.95]
Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and ...[ Price : $8.95]
FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.