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Amgen submits a BLA for evolocumab seeking approval for treating high cholesterol.[ Price : $8.95]
Takeda says a 10-year epidemiology study has shown no overall statistically significant increased risk of bladder cancer in patien...[ Price : $8.95]
CDER issues a MAPP with priorities and time periods for posting drug approval information on the Centers Web site.[ Price : $8.95]
Pfizer asks FDA to set specific early exposure BE criteria for drug products referencing its ADHD drug Quillivant XR.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on recommendations for screening, testing, and management of blood donors and blo...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Electronic Exchange of Documents: File Format Recommendations (VICH GL53) ...[ Price : $8.95]
FDA has accepted for filing a Mylan ANDA for a three-times-per-week glatiramer acetate injection 40 mg/mL, a generic of Tevas MS d...[ Price : $8.95]
BIO and Novartis voice disagreement with FDAs proposed use of Phonetic and Orthographic Computer Analysis scores in determining th...