FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.
AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...
Sen. Ron Wyden calls on FDA and the DEA to issue a joint statement on the current Adderall shortage and to answer questions about its work in addressi...
Federal Register notice: FDA makes available a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.
Federal Register notice: FDA withdraws approval of a Vintage Pharmaceuticals ANDA for pemoline tablets after the company requested its withdrawal.
Federal Register notice: FDA issues a priority review voucher to Krystal Biotech in response to an approved rare pediatric disease product application...
FDA publishes an International Council for Harmonization draft guidance on good clinical practices intended to improve clinical trials.
FDA warns Henderson, NV-based Steiner Biotechnology about multiple violations in its production and labeling of several dental bone grafting products.
