[ Price : $8.95]
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufact...[ Price : $8.95]
Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace ...[ Price : $8.95]
Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit th...[ Price : $8.95]
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition o...[ Price : $8.95]
FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency...[ Price : $8.95]
Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving fe...[ Price : $8.95]
FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for ...[ Price : $8.95]
Law firms Hogan Lovells and Foley and Lardner advise pharmaceutical and medical device companies to maintain full inspection readi...