FDA medical reviewers tell members of the Arthritis Advisory Committee they have serious safety concerns about Lillys proposed arthritis drug Olumiant...
FDA clears an Arthrosurface 510(k) to market the OVOMotion Shoulder Arthroplasty System that the company says is intended to provide surgeons with an ...
FDA expands approval for AstraZenecas Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose...
FDA releases an ICH guidance with answers to questions about its Q7 guidance on good manufacturing practices for APIs.
FDA says healthcare providers should not use the Erbe USA Erbeflo 24-hour multi-patient endoscope connector because it does not adequately mitigate ri...
FDA approves a Rigel Pharmaceuticals NDA for Tavalisse (fostamatinib disodium hexahydrate) for treating thrombocytopenia in adult patients with chroni...
FDA clears a Cantel Medical 510(k) for its Advantage Plus Pass-Thru automated endoscope reprocessor.
FDA releases an FDA-483 with 10 observations from an inspection at Coastal Meds outsourcing facility.