[ Price : $8.95]
FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi su...[ Price : $8.95]
Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.[ Price : $8.95]
FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate developme...[ Price : $8.95]
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient s...[ Price : $8.95]
FDA asks manufacturers of generic Accutane to update the drugs labeling.[ Price : $8.95]
FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accele...[ Price : $8.95]
FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the...[ Price : $8.95]
FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for t...