FDA reviewers appear open to considering accelerated approval for Biogens amyotrophic lateral sclerosis drug tofersen in patients with the superoxide ...
Federal Register notice: FDA makes available a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical I...
FDA accepts for review an Ipsen resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressive.
FDA tells Sarepta Therapeutics that it has decided to hold an advisory committee meeting to review its gene therapy BLA for SRP-9001 (delandistrogene ...
FDA posts a draft guidance entitled Pharmacogenomic Data Submissions that discusses the use of such data in drug development.
Federal Register notice: CDER announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
FDA issues Olympus Medical Systems a Warning Letter after inspecting the firms Tokyo facility and documenting GMP deficiencies.
A federal judge approves a $25 million class action settlement involving Johnson & Johnsons Remicade (infliximab).
