Controlled-Release AZT Gets FDA Go-Ahead for New Drug Investigation
SAN DIEGO--Genta Jago, a joint venture between Genta Incorporated and Jagotec AG (Hergiswil, Switzerland), has filed an Investigational New Drug application with the FDA for a controlled-release formulation of zidovudine (AZT), marketed
SAN DIEGO--Genta Jago, a joint venture between Genta Incorporatedand Jagotec AG (Hergiswil, Switzerland), has filed an InvestigationalNew Drug application with the FDA for a controlled-release formulationof zidovudine (AZT), marketed by Burroughs Wellcome Co. as Retrovir.
The recommended dosage for AZT in the United States is six timesdaily. Results of pilot in vitro and human pharmacokinetic studiesin Europe suggest that once- or twice-daily dosing may be possiblewith the controlled-release formulation, which incorporates Jagotec'sGeomatrix delivery technology.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
