je.st

Home › fdaapproved

Tag: fdaapproved

Pfizer's RAPAMUNE (sirolimus) Becomes First FDA-Approved Treatment For Lymphangioleiomyomatosis (LAM), A Rare Progressive Lung Disease

2015-06-03 06:19:12| drugdiscoveryonline Home Page

Pfizer Inc. announced recently that the U.S. Food and Drug Administration (FDA) has approved RAPAMUNE (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive disease that affects the lungs, kidneys and the lymphatic system

Tags: treatment disease rare progressive

Merck Receives Accelerated Approval of KEYTRUDA (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy

2014-09-04 21:15:00| Merck.com - Corporate News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046orClaire Mulhearn, 908-423-7425orInvestor:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: approval therapy receives accelerated

Bayer Launches FDA-Approved Soft Chew for Canine Osteoarthritis Pain Management

2014-07-01 22:09:47| Chemicals - Topix.net

Bayer HealthCare LLC Animal Health is pleased to announce the launch of quellin soft chewable tablets to help alleviate the pain associated with canine osteoarthritis, one of the most common causes of chronic pain in dogs-affecting 20 percent of dogs older than one year of age.

Tags: management soft pain launches