News

Zacks Investment Research on MSN14h
FDA Grants Label Expansion to AstraZeneca's Datroway in Lung Cancer
AstraZeneca AZN announced that the FDA has expanded the label of its cancer drug Datroway for a second indication — non-small ...
The Regulatory Review23h
Making Drugs Affordable Through Personal Importation
FDA’s public guidance continues to warn that, “under most circumstances,” importing drugs for personal use is unlawful, ...
pharmaphorum12d
FDA clears Nuvation's first product Ibtrozi, for lung cancer
Nuvation Bio is set to launch its first commercial product after the FDA approved its ROS1 inhibitor Ibtrozi as a treatment ...
PMLive18h
AstraZeneca/Daiichi Sankyo’s Datroway granted FDA accelerated approval for lung cancer
AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been granted accelerated approval by the US Food ...
First Study Site Established for Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of ...
BioSpace11d
UroGen’s Bladder Cancer Drug Wins FDA Approval Over Adcomm’s Objections
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely ...
PharmExec13d
FDA Approves Azurity Pharmaceuticals’ Xifyrm for Moderate-to-Severe Pain Management
Delivered as a once-daily 30 mg/mL IV bolus injection over 15 seconds, Xifyrm can be used alone or alongside non-NSAID ...