[ Price : $8.95]
FDA grants Astellas an orphan drug designation for isavuconazole and its use in treating invasive candidiasis.[ Price : $8.95]
FDA accepts for review a Boehringer Ingelheim NDA for Spiriva Respimat (tiotropium bromide) inhalation spray that is seeking an in...[ Price : $8.95]
CDER director Janet Woodcock discusses collaborative efforts to advance regulatory science.[ Price : $8.95]
Amgen petitions FDA to require biosimilar applications to include a certification by the applicant that they will provide the refe...[ Price : $8.95]
In an unprecedented move, FDA issues a statement to clarify that data integrity or fraud is not at the center of why Sarepta Thera...[ Price : $8.95]
The HHS Office of the Inspector General announces its Work Plan for fiscal year 2015 that targets five FDA drug program areas.[ Price : $8.95]
FDA approves a Lannett Co. ANDA for letrozole tablets USP, 2.5 mg, a generic copy of Novartis Femara tablets.[ Price : $8.95]
FDAs Cardiovascular and Renal Drugs Advisory Committee recommends approval of Daiichi Sankyos once-daily Savaysa (edoxaban) 60 mg ...