FDA delays Genesense approval
The FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker Genta said. CDER has asked the company to come up with confirmatory evidence for the drug.
- Lytix Biopharma to conduct clinical trials for LTX-315
- Health Canada approval to Revlimid
- ImClone launches ERBITUX® in Canada
- Health Canada approves VELCADE for multiple myeloma
