[ 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]
Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignati...[ Price : $8.95]
A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals fo...[ 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...