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Zacks Investment Research on MSN19h
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 ...
MedPage Today on MSN13d
Non-Surgical Option Approved for Recurrent Low-Grade Bladder Cancer
The FDA approved mitomycin intravesical solution (Zusduri) as a nonsurgical option for recurrent low-grade, intermediate-risk ...
BioSpace1d
IRA Leaves Orphan Drugs Stranded Even as Regulators Promise Progress
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from ...
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 ...
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 ...
Targeted Oncology6d
FDA Approves Label Update But Not Expansion for Talazoparib/Enzalutamide in mCRPC
FDA updates talazoparib and enzalutamide labeling, confirming survival benefits for HRR-mutated mCRPC, while excluding ...
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 ...