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Published: Tue, 31 Oct 2017 14:16:39 -0400

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Once-Weekly Diabetes Treatment Gets FDA OK

Fri, 27 Jan 2012 17:22:39 -0400

WASHINGTON -- The delay is over for the diabetes drug Bydureon (exenatide extended-release), with FDA approval making it the first once-weekly treatment for type 2 disease.



FDA OKs Axitinib for Kidney Cancer

Fri, 27 Jan 2012 15:37:41 -0400

Another angiogenesis blocker, axitinib (Inlyta), has won FDA approval as a second-line treatment for advanced kidney cancer, the agency said Friday.



Federal Injunction Blocks Ranbaxy from Marketing in U.S.

Wed, 25 Jan 2012 18:44:06 -0400

WASHINGTON --The Justice Department filed a consent decree today preventing generic drug giant Ranbaxy from selling drugs made at four of its manufacturing plants until it brings them into compliance with the FDA's quality standards.



FDA Allows Vytorin Labeling for Use in Kidney Disease

Wed, 25 Jan 2012 17:22:24 -0400

The FDA has approved new labeling for the single-tablet combination of ezetimibe-simvastatin (Vytorin), a cholesterol-lowering drug, for use in patients with moderate to severe chronic kidney disease.



End Near for Fabry Drug Shortage

Tue, 24 Jan 2012 11:55:21 -0400

The FDA has approved production of an enzyme replacement therapy for Fabry disease at a new manufacturing plant, and the maker expects a two-year long shortage of the drug to be over by March.



Bortezomib OK'd for SQ Delivery

Mon, 23 Jan 2012 17:15:00 -0400

Subcutaneous administration of bortezomib (Velcade) has received FDA approval for both of the drug's currently recognized indications, its manufacturer said.



FDA OKs Treatment for Toxic Chemo Drug Levels

Wed, 18 Jan 2012 14:16:47 -0400

WASHINGTON -- The FDA has approved the enzyme glucarpidase (Voraxaze) for treatment of toxic levels of the chemotherapy drug methotrexate in the blood due to kidney failure.



More PML Cases Turn Up With Adcetris

Fri, 13 Jan 2012 13:43:45 -0400

Two new cases of a life-threatening brain inflammation have been seen in patients treated with the lymphoma drug brentuximab vedotin (Adcetris), the FDA said.



Glass Particles Prompt Recall of Injectables

Fri, 13 Jan 2012 11:30:00 -0400

The maker of an injectable polymyxin B and vecuronium bromide has recalled several lots of each product because of glass particles in the solutions.



FDA Warns of Opioid Drug Mix-Up

Mon, 09 Jan 2012 12:17:44 -0400

The FDA has issued a warning that pills, tablets, or caplets of Percocet and eight other opioid products packaged by Novartis for Endo Pharmaceuticals may have been mixed up, with one drug being packaged as another.



FDA Grants Orphan Status to HCMV Drug

Sun, 08 Jan 2012 14:00:00 -0400

WASHINGTON -- The FDA has granted orphan drug status to the novel human cytomegalovirus (HCMV) inhibitor AIC246 (Letermovir) for the prevention of HCMV-related viremia and disease in at-risk patients.



FDA Expands Label for Hereditary Angioedema Drug

Wed, 04 Jan 2012 15:41:39 -0400

WASHINGTON -- The FDA has expanded the label of the C1 esterase inhibitor Berinert to allow for self-treatment of hereditary angioedema during acute attacks and for use in laryngeal attacks.



FDA Okays BP Drug Combo

Fri, 23 Dec 2011 13:00:00 -0400

WASHINGTON -- The FDA has approved a single-tablet formulation of azilsartan medoxomil and chlorthalidone for hypertension treatment in adult patients.



Death of MS Patient Prompts FDA Fingolimod Review

Wed, 21 Dec 2011 11:16:52 -0400

The death of a multiple sclerosis patient shortly after a first dose of fingolimod (Gilenya) is under review by the FDA, the agency said.



FDA Flips on Simvastatin Dose With Amiodarone

Sun, 18 Dec 2011 13:00:00 -0400

WASHINGTON -- The FDA has revised the daily dosing limits on the cholesterol drug simvastatin in combination with the antiarrhythmic agent.