[ Price : $8.95]
FDA reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Sign...[ Price : $8.95]
FDA accepts for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressiv...[ Price : $8.95]
FDA tells Sarepta Therapeutics that it has decided to hold an advisory committee meeting to review its gene therapy BLA for SRP-90...[ Price : $8.95]
FDA posts a draft guidance entitled Pharmacogenomic Data Submissions that discusses the use of such data in drug development.[ Price : $8.95]
Federal Register notice: CDER announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interactio...[ Price : $8.95]
FDA issues Olympus Medical Systems a Warning Letter after inspecting the firms Tokyo facility and documenting GMP deficiencies.[ Price : $8.95]
A federal judge approves a $25 million class action settlement involving Johnson & Johnsons Remicade (infliximab).