Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Mercks psoriasis drug Ilumya (tildrakizumab).
FDA releases a final guidance on Bone Anchors Premarket Notification (510(k)Submissions.
CDERs Office of Prescription Drug Promotion (OPDP) sends Outlook Pharmaceuticals a Warning Letter over a sponsored link on Googles search engine for P...
FDA approves a Biohaven Pharmaceutical NDA for Nurtec ODT (rimegepant) for the acute treatment of migraine in adults.
Sanofi-Aventis agrees to pay almost $12 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients ...
FDA accepts for review a Pfizer and Eli Lilly BLA for tanezumab 2.5 mg administered subcutaneously for patients with chronic pain due to moderate-to-s...
FDA approves a Sanofi BLA for Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone for treating adults with relapsed refracto...
FDA clears an FX Shoulder 510(k) for its Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplast...