Regulatory Affairs Syndicator

October 5, 2009 — Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years — since the Eisenhower Administration.

CVRx, Inc. reported the first enrollment of a patient in the HOPE4HF Trial, a study that is evaluating the Rheos System to treat heart failure.

Relatives of a Nebraska woman who died after eating tainted spinach will travel to Washington on Tuesday to raise awareness of foodborne illness.

Main Category: Respiratory / Asthma Also Included In: Medical Devices / Diagnostics Covidien , a leading global provider of healthcare products and recognized innovator in mechanical ventilation and respiratory care devices, today announced that it has received 510 clearance from the U.S. Food and Drug Administration to market its Mallinckrodt …

The U.S. Food and Drug Administration announced has banned candy-, fruit- and clove-flavored cigarettes, which health and federal authorities say are more appealing to youth.

The United States is prepared to make 10 percent of its H1N1 vaccine supply available to other countries, an announcement by the White House said Thursday.

Hyperion Therapeutics, Inc. announced that its investigational product HPN-100 has received orphan product designation from the U.S. Food and Drug Administration for intermittent or chronic treatment of patients with cirrhosis and any grade of hepatic encephalopathy.

RICHMOND, Va. a ‘ The nation’s top distributor of clove cigarettes is offering fans a new way to get their fix after the spice-flavored cigarettes are banned later this year a ‘ cigars.

Spectrum Pharmaceuticals , a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN , a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma , who achieve …

Consumers know less about the water they pay dearly for in bottles than what they can drink almost for free from the tap because the two are regulated differently, congressional investigators and nonprofit researchers say in new reports.

Main Category: Blood / Hematology Also Included In: Clinical Trials / Drug Trials Article Date: 24 May 2009 Seattle Genetics, Inc.

Main Category: Pain / Anesthetics Also Included In: Clinical Trials / Drug Trials ; Pharma Industry / Biotech Industry Article Date: 12 Jul 2008 - 0:00 PDT NeurogesX, Inc.

GlaxoSmithKline Plc does not expect to win U.S. approval for its key cervical cancer vaccine Cervarix until late 2009, marking a further delay for the product.

Oncolytics Biotech Inc. announced today that following U.S. Food and Drug Administration review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in …

Here are some of the latest health and medical news developments, compiled by editors of HealthDay: Three-quarters of American adults are stressed about money and worried about their financial future, according …