Ofatumumab approved for advanced CLL
- Ofatumumab approved for advanced CLL. Traynor, Kate // American Journal of Health-System Pharmacy;12/1/2009, Vol. 66 Issue 23, p2062
The article reports on the approval by the Food and Drug Administration on ofatumumab for the treatment of chronic lymphocytic leukemia (CLL) in the U.S. It is stated that the said drug from GlaxoSmithKline and Benmab A/S is used for the treatment of CLL patients whose cancer does not respond to...
- Recently Approved. // Pharmaceutical Representative;Nov2006, Vol. 36 Issue 11, p14
The article presents several drugs that are recently approved by the Food and Drug Administration in the U.S. It includes Fentora (fentanyl buccal tablet) from Cephalon Inc. to reduce pain in the opioid therapy of cancer patients, GlaxosmithKline PLC's Lamictal (lamotrigine) tablets as...
- Genmab, GSK Submit BLA for Arzerra in CLL. // Bioworld Week;2/9/2009, Vol. 17 Issue 6, p3
The article reports on the submission of a biologics license application (BLA) to the Food and Drug Administration for the approval of Arzerra by Genmab AS and GlaxoSmithKline PLC. It mentions that the said drug will be used in treating patients with drug-resistant chronic lymphocytic leukemia...
- FDA grants breakthrough therapy designation to two leukemia drugs. // Hem/Onc Today;11/10/2013, Vol. 14 Issue 21, p38
The article reports on the breakthrough therapy designation granted by the U.S. Food and Drug Administration (FDA) for ofatumumab and volasertib used for the treatment of leukemia, and also offers information on the designation and indications for the two drugs.
- Quick success for cancer kinase treatment. // Nature Medicine;Jun2001, Vol. 7 Issue 6, p637
Focuses on the approval of the drug STI571 for the treatment of chronic myeloid leukemia (CML) by the U.S. Food and Drug Administration. Health effects of CML; Benefits of STI571 therapy.
- Consumer Media Versus FDA. Henderson, Lisa // Applied Clinical Trials;Aug2007, Vol. 16 Issue 8, p12
The author reflects on the issues concerning the postmarketing drug newsletter of the pharmaceutical industries in the U.S. She states that the Food and Drug Administration (FDA) has intended to launch a newsletter on its web site to inform the public about drug safety, but she stresses that...
- Pipeline preview. // Formulary;May2007, Vol. 42 Issue 5, p282
The article presents several approvable and nonapprovable drugs by the U.S. Food and Drug Administration. The Armodafinil, which treats excessive sleepiness with narcolepsy, obstructive sleep apnea or hypopnea syndrome, and shift work sleep disorder, is recommended for approval. The Etoricoxib,...
- Acorda Therapeutics wins FDA approval for multiple sclerosis. // PharmaWatch: Biotechnology;Mar2010, Vol. 9 Issue 3, p13
The article reports on the marketing approval for the symptomatic multiple sclerosis (MS) drug Ampyra from Acorda Therapeutics Inc. by the U.S. Food and Drugs Administration (FDA).
- GlaxoSmithKline: reformulation of Parkinson's drug set for success. // PharmaWatch: CNS;May2007, Vol. 6 Issue 5, p4
The article reports on the application for approval of the once-daily formulation of GlaxoSmithKline's Parkinson's disease drug Requip with the Food and Drug Administration in the U.S. The extended-release formulation of Requip, a dopamine agonist for the treatment of PD will be marketed as a...