Regulatory Affairs Syndicator

SAN FRANCISCO (AFX) — ImmunoGen Inc. said late Tuesday it has been notified by Genentech Inc. that the trastuzumab-DM1 investigational new drug application submitted by Genentech to the Food and Drug Administration has become effective, triggering a $2 million milestone payment to ImmunoGen.

WASHINGTON The Food and Drug Administration has approved a drug to treat chronic adult constipation.

MSN MoneyCentral - NORTHVALE, N.J. (AP) - Elite Pharmaceuticals Inc. on Tuesday said the has accepted its investigational new-drug application for OxyQD, its once-a-day oxycodone painkiller. Shares of Elite jumped on the news, climbing 15 …

Jan. 31, 2005 - The maker of contaminated dog food that led to the deaths of dozens of dogs is acknowledging that workers at its Gaston manufacturing facility failed to follow internal procedures for testing …

The Food and Drug Administration said Tuesday it has approved CV Therapeutics’ Ranexa for chronic angina.

WASHINGTON, Jan. 31 (UPI) — The Food and Drug Administration said Tuesday it has approved CV Therapeutics’ Ranexa for chronic angina. Ranexa is a new molecular entity and the first drug the agency has approved to treat chronic angina, typified by chest pain, in over a decade, the FDA said.

US health officials have approved a new prescription drug, called Amitiza, to treat adults with chronic constipation, one of the most common disorders among Americans.

TORONTO & WINNIPEG, Canada, Jan. 31 /PRNewswire-FirstCall/ — Cangene today announces that the U.S. Food and Drug Administration (FDA) has approved an expanded access investigational new drug (IND) protocol for use of VariZIG(TM), Cangene’s Varicella immune globulin.

BETHESDA, Md., Jan. 31 /PRNewswire/ — Sucampo Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved the new drug application for AMITIZA(TM) (lubiprostone) capsules, an oral treatment of chronic idiopathic constipation in adults.

Biotech firm ImmunoGen Inc. said Tuesday an application for a drug developed using its anti-cancer technology has been declared effective by the Food and Drug Administration, triggering a $2 million milestone payment to ImmunoGen.

BETHESDA, Md., Jan. 31 (UPI) — Sucampo said Tuesday it has been approved to market Amitiza capsules to treat chronic constipation. The drug maker said the Food and Drug Administration has OK’d the new drug (lubiprostone) as an oral treatment of chronic idiopathic constipation in adults.

Lubiprostone works by increasing the secretion of intestinal fluids, which help ease the passage of stool and alleviate symptoms associated with chronic idiopathic constipation, the Food and Drug Administration …

A drug to treat adult chronic constipation with no known cause won federal approval Tuesday. Lubiprostone works by increasing the secretion of intestinal fluids, which help ease the passage of stool and alleviate symptoms associated with chronic idiopathic constipation, the Food and Drug Administration said.

Health News BriefsNPR - 19 hours agoNPR.org, January 31, 2006 · People who need insulin now have an alternative to injections: The Food and Drug Administration (FDA) has approved an inhalable … Drugs and Liability Washington PostFDA Proposes L…

ABC News - DUBLIN, Ireland Jan 31, 2006 — Ireland’s leading drug maker Elan Corp. PLC, which is awaiting U.S. approval on a key suspended drug, reported heavy fourth-quarter losses on Tuesday but expressed hopes of a rebound this year. Elan said it lost $58.3 …