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FDA Panel Okays FluMist for Kids
MedImmune, announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in ...

FDA Advisory Committee Recommends New Restrictions For Anemia Medications
An FDA advisory committee recommended that the agency place new restrictions on anemia medications manufactured by Amgen and Johnson & Johnson because...

FDA Approves New Dosage Strength Of FOSAMAX PLUS D
Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new dosage of FOSAMAX PLUS D (alendronate sodium/cholecalc...

FDA Re-inspection Results in Positive Re-classification of Guayama Facility
Wyeth announced that the U.S. Food and Drug Administration’s (FDA) San Juan District Office has informed the Company that the recent FDA re-inspection...

HealthTronics Announces FDA Clearance and Launch of the New LithoDiamond ULTRA Lithotripter
HealthTronics, provider of urology services and products, announced the launch of its LithoDiamond ULTRA lithotripter providing an evolution in lithot...

Monebo Technologies Obtains FDA Clearance to Market the CardioBelt™ Wireless ECG System
Monebo Technologies, announced that the CardioBelt Electrode System is now available, following clearance by the United States Food and Drug Administr...

EtQ Announces Software for Electronic Submissions to the FDA
EtQ has released the beta version of the EtQ Reliance eMDR Submission Tool, enabling Medical Device Manufacturers to electronically submit Medical Dev...

FDA Approves SCHWARZ PHARMA's Neupro® (Rotigotine Transdermal System) For Treatment Of Early-stage Parkinson's DIsease
SCHWARZ PHARMA announced today that the U.S. Food and Drug Administration (FDA) has approved Neupro (Rotigotine Transdermal System) for the treatment ...

FDA Advises Manufacturers to Test Glycerin for Possible Contamination
The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound ...

FDA Approves Aastrom Phase III IND for Treatment of Osteonecrosis of the Femoral Head
astrom Biosciences, a regenerative medicine company, announced that the U.S. Food & Drug Administration (FDA) approved the Company's Investigational N...

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