Federal Register Notice: FDA announces a 4/4 advisory committee meeting to discuss over-the-counter analgesic combination products used for upset stom...
FDA awards Biogen a priority review voucher (PRV)for gaining approval of rare disease drug Spinraza (nusinersen), indicated for treating spinal muscul...
FDA approves a Serenity Pharmaceuticals NDA for Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urina...
FDA approves a Lupin Ltd. ANDA for a generic copy of Braintree Laboratories Suprep Bowel prep kit.
Alliance for a Stronger FDA deputy executive director Steven Grossman says the agency is at risk in the coming Trump Administration budget request and...
FDA approves Merck, Sharp & Dohmes Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite-ind...
A Delaware federal judge dismisses Genentechs BPCIA suit alleging Amgen failed to meet terms of the BPCIA in its application for a biosimilar Avastin....
A University of California Institute for Innovation Law study indicates that drug companies are increasingly using the citizen petition process in an ...