approval

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

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

Vivus has a potential upside of 16.6% based on a current price of $8.21 and an average consensus analyst price target of $9.57.

Vivus (NASDAQ:VVUS) said its effort to win regulatory approval for its weight-loss pill Qnexa may be helped by a study showing little risk of birth defects in children of women who took one of the medicine's ingredients, according

Hi-Tech Pharmacal announced that the FDA granted tentative approval for the company's Abbreviated New Drug Application for levofloxacin oral solution 25mg/mL, the generic for McNeil Pharmaceutical's Levaquin oral solution which ha

On Wednesday, MDT said the FDA sent the company a letter in Q3 of fiscal 2011 declining to approve its Amplify rhBMP-2 Matrix bone graft material without additional information from MDT, Reuters reports.

MDT did not say what additional information the FDA sought but said that the company was continuing to seek FDA approval for the product.

Medtronic (MDT) is lower after it said the FDA rejected its Amplify product, which aims to use a protein to stimulate bone growth and relieve low back pain.

Good Morning. It's Tuesday, March 1, 2011. At this hour, U.S. equity futures are up. Overseas, the Asian markets gained, while the European markets are higher. HCN (HCN) to acquire real estate assets of Genesis HealthCare for

Health care shares are higher Monday. Bloomberg is reporting that a high school teacher in Tasmania is suing Johnson & Johnson over an implanted hip-replacement device that stopped selling in Australia due to defects. Meanwhil

The FDA approval is based on a nine-week placebo controlled study of Intuniv in combination with other drugs to treat ADHD. The company, however, stated that the drug should be one part of a comprehensive treatment program that ma

Shire (SHPGY) announced that it has received approval from The U.S. Food and Drug Administration (FDA) for a new indication for Intuniv, its Attention Deficit Hyperactivity Disorder drug, the Boston Business Journal reports.

Matrix has received final approval from the FDA for Gabapentin Capsules. The drug is a generic version of Pfizer's Neurontin. It's used to treat a painful complication of shingles.

Matrix's Gabapentin had U.S. sales of about $300 million last year. The drug-maker is launching this product immediately.

Mylan Inc. (MYL) is up nearly 3% Monday, on news from its subsidiary, Matrix Laboratories.

Teva said results from a Phase III study of QNAZE HFA, its nasal aerosol corticosteroid in development to treat perennial allergic rhinitis (PAR) and seasonal allergic rhinitis, achieved all primary and secondary efficacy endpoint

Teva shares are down 0.9%, or $0.46, to $51.56.

Teva Pharmaceuticals (TEVA) shares are down fractionally, despite positive drug trial news.