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Entries Tagged ‘Drug Administration’

Stroke Patients On Warfarin Can Be Safely Treated With Clot-Busting Drug

Acute ischemic stroke patients taking the blood thinner warfarin can be treated safely with the clot-busting drug tissue plasminogen activator (tPA), according to research presented at the American Heart Association’s Quality of Care and Outcomes Resea…

Denosumab (Xgeva) Not Approved For Metastasis Prevention

Amgen’s application for expanded indications for denosumab (Xgeva) were turned down by the FDA (Food and Drug Administration) – the expanded indications were to include bone metastases prevention in patients with castration-resistant prostate cancer. T…

Two Takeda Diabetes Drug Applications, FDA Asks For More Info

Takeda says it has received a complete response letter from the FDA regarding NDAs (new drug applications) for alogliptin and fixed-dose combination alogliptin and pioglitazone – both diabetes type 2 investigational therapies. Takeda says it has recent…

Chronic Migraine Headache Sufferers Benefit Only Modestly From Botox Injections

A study published in the April 25 issue of JAMA reveals that individuals suffering from chronic migraine headaches and chronic daily headaches may receive a small to modest benefit using botulinum toxin A (“Botox”) injections. However, the researchers …

Monitoring Medications After Approval Has Improved Oversight, Says CDER

A more robust postmarket drug safety program has helped improve the FDA’s (Food and Drug Administration) oversight of medications after they have been approved, says a report issued by CDER (Center for Drug Evaluation and Research). CDER is part of the…

Victoza Superior To Januvia In Blood Sugar And Body Weight Control

Diabetes drug Victoza (liraglutide [rDNA] injection) has been shown to be superior to Januvia (sitagliptin) in achieving body weight reduction and blood sugar control, Novo Nordisk has announced. The drug’s label in the USA has been updated, demonstrat…

Votrient (Pazopanib) Gets FDA Panel Green Light For Advanced Soft Tissue Sarcoma Treatment

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Votrient (pazopanib) for the treatment of the rare cancer advanced soft tissue sarcoma. Patients who were already administered chemotherapy will be eligible for pazopa…

Anti-NGF Testing – FDA Committee Says "Yes"

The development of Anti-NGF (anti-nerve growth factor) class of drugs should go ahead, the Arthritis Advisory Committee has told the FDA. The Committee is an advisory body that recommends what the FDA (Food and Drug Administration) should do. Although …

Gerber Baby Foods Recalled Because Of Strange Smell

The FDA and the Gerber Products Company yesterday announced the recall and replacement of Gerber Good Start Gentle powdered infant formula, in 23.2 ounce plastic packaging. The FDA (Food and Drug Administration) wrote on its website that the recall is …

First Quadrivalent Vaccine Against Seasonal Flu Wins FDA Approval

On Wednesday, the US Food and Drug Administration announced it had approved FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people aged 2 to 49 years. This is the first quadrivalent flu vaccine, that is one that contains four strains …