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Novagali Pharma Receives US FDA Orphan Drug Designation for Vekacia(R) for the Treatment of Vernal Keratoconjunctivitis
Novagali Pharma, an emerging ophthalmic pharmaceutical company, announced orphan drug designation granted by the U.S. Food and Drug Administration (FD...

FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release Tablets for the Treatment of Schizophrenia
AstraZeneca announced that the FDA has approved SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of...

FDA Approves Lovenox (Enoxaparin Sodium Injection) for the Most Severe Type of Heart Attack
Sanofi-aventis announced that the FDA has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox (enoxaparin sodium injecti...

Casewise Earns the Highest Score for its 'Current Offering' in Enterprise Architecture Modeling Software
Casewise announced that it was named a leader and earned the top score for its 'Current Offering' in the recently published independent market assess...

FDA Approves Dey, L.P.'s Perforomist Inhalation Solution For Maintenance Treatment Of COPD
Dey has announced that the FDA has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, tw...

FDA Approves Expanded Use for Surgical Sealant
The U.S. Food and Drug Administration (FDA) approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from sma...

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...

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