fda

The FDA approval means that patients who have primary immunodeficiency will be able to self inject the drug--Gammagard Liquid--at home, if recommended by a doctor. Previously the drug was only accessible through intravenous infusi

Baxter said that new administration route would give patients greater flexibility in receiving treatments.

Baxter International (NYSE:BAX) announced Monday that a prescription drug for patients with dysfunctional immune systems has been approved for below-the-skin injection.

The approval is based upon the results from two studies, a Phase II, multicenter, international, open-label, single-arm study of ISTODAX in patients with PTCL who had failed at least one prior therapy, and a single-arm clinical st

Celgene has a potent

Celgene (NASDAQ:CELG) announced that the FDA granted accelerated approval for its Supplemental New Drug Application for an additional indication for ISTODAX for injection for the treatment of peripheral T-cell lymphoma in patients

In a 700-person study, 350 were given Chantix while the other half were given a placebo according to the FDA. Chantix did help those patients quit smoking, 47% went without smoking for four weeks, 2% of the Chantix group had a non

The Food and Drug Administration said Thursday that Pfizer Inc.'s (NYSE:PFE) product Chantix, which is supposed to help in the quitting of smoking, might increase the risk of heart disease.

The purchases will come over a 5-year period, for inclusion in the United States' "Strategic National Stockpile (SNS)."

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions said, "Emergent is pleased to be in active discussions with the U.S.

Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. government plans to award the company a sole source contract of the purchase of 44.75 million doses of BioThrax, the only vaccine licensed by the U.S. Food and Dr

Vertex Pharmaceuticals (VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved its INCIVEK (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver di

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 8. The PDUFA date is the target date for the FDA to complete its review of the NDA.

Antares Pharma (AIS) says the New Drug Application (NDA) for Anturol Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel inc