verywellhealth7h
The Surprising Role of Ketamine in Combatting Depression: A Pharmacist's Insight
Learn more about how an anesthetic traditionally used for surgical procedures may help depression and what to expect during ...
Autolus Therapeutics Wins FDA Approval for AUCATZYL®
Autolus Therapeutics ( (AUTL) ) has provided an announcement. Autolus Therapeutics has achieved a pivotal milestone with the FDA’s ...
FiercePharma11h
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New Drug Application (sNDA)
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...