As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA implements a new policy to permit cer...
Federal Register notice: FDA determines that CIS Bio Internationals Neo Tect Kit was not withdrawn from sale for safety or effectiveness reasons.
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...