FDA UPDATES

House Introduces Bill to Expedite FDA Drug Review

 A new House bill—the Drug Shortage Prevention Act (H.R. 3839)— received bipartisan support to expedite the FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply.

FDA Updates Imatinib's Label to 36 Months of Use after Removal of GIST

 The US Food and Drug Admin - istration (FDA) approved an updated label for imatinib (Gleevec; Novartis) for the use of the drug in adults after the surgical removal of CD117-positive gastrointestinal stromal tumors (GIST).

Bosutinib NDA Accepted for CML

Boxed Warning, New Contraindication Added to Brentuximab’s Label

Topical Gel for Actinic Keratosis

Subcutaneous Bortezomib a New Therapeutic Option

FDA Approves Axitinib for Advanced Renal-Cell Carcinoma

Erivedge First Drug Ever for Metastatic Basal-Cell Carcinoma

FDA Updates OS Label Data for Bortezomib in Myeloma

Cetuximab Gains New Indication for Metastatic Head/Neck Cancer