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About 1047 results for "us food drug administration"

FDA panel unanimously backs Novartis' psoriasis drug
Reuters India

US FDA committee recommends approval of Novartis' secukinumab ...

The US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously to support the approval of Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment of ... PharmaBiz, 6 hours ago
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Nasdaq

Tonix Pharmaceuticals receives IND clearance for TNX-201 in Episodic Tension-Type Headache

1:40pm BST Tonix Pharmaceuticals Holding Corp:Says the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application to study TNX-201 for the treatment of episodic tension-type headache.Tonix will evaluate the ...
 Reuters UK2 hours ago West Pharmaceutical Services receives U.S. FDA 510(k) clearance and CE Mark  Reuters2 hours ago West's Vial2Bag DC Device Receives U.S. FDA 510(k) Clearance and CE Mark  Individual.com5 hours ago WEST PHARMACEUTICAL SERVICES : Vial2Bag DC Device Receives U.S. FDA 510(k) Clearance and CE Mark  4 Traders5 hours ago
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Boston Globe

FDA expected to issue rule on food additives process by 2016

NEW YORK, Oct 20 (Reuters) - The U.S. Food and Drug Administration is expected to issue a final rule on its controversial food additive approval process by August 2016 as part of a legal settlement, according to court papers filed on Monday. ...
 CNBC18 hours ago What I learned at Food Boot Camp  Boston Globe1 day ago Comments by Dr. Gary A. Puckrein on the Food and Drug Administration's FDASIA Section 907 Action Plan October 20, 2014  National Minority Quality Forum19 hours ago FDA Issues Recommendations for Animal Drug Sponsors  ALN3 days ago
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PR Newswire

FDA Accepts Lilly's NDA Filing For Empagliflozin/metformin Combination

Eli Lilly and Co. (LLY: Quote) Tuesday said the U.S. Food and Drug Administration or FDA has accepted its filing of New Drug Application or NDA for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, which is an ...
 RTTNews.com4 hours ago U.S. Food and Drug Administration accepts filing of new drug application for empagliflozin/metformin fixed-dose combination  Stockwatch4 hours ago Eli Lilly : U.S. Food and Drug Administration accepts filing of new drug application for empagliflozin/metformin fixed-dose combination  4 Traders4 hours ago
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Med India

Analysts see U.S. approval of Novo Nordisk's obesity drug by year-end

(Reuters) - The U.S. Food and Drug Administration is likely to approve Novo Nordisk's new drug to treat obesity this year, analysts said after wide expectations of an FDA decision late on Monday were not met. Danish drugmaker Novo Nordisk applied ...
 Reuters7 hours ago Analysts Predict FDA Approval Of Novo Nordisk A/S's Obesity Drug By Year-End  BioSpace5 hours ago US Panel Backs Novo's Obesity Drug  Med India1 month ago
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Results from Two Phase III Studies Added to U.S. Label of Genzyme's Aubagio

CAMBRIDGE, Mass.---- Genzyme, a Sanofi company, announced today that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio ® in the product' s U.S.
 CNBC1 day ago Results From Two Phase 3 Studies Added To U.S. Label Of s Aubagio  BioSpace21 hours ago
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Pharma Letter

FDA accepts Eisai's sNDA for perampanel drug for treatment of PGTC seizures

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's Supplemental New Drug Application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel for the treatment of primary ...
 News-Medical.Net9 hours ago FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures  Pharma Letter1 day ago U.S. FDA Accepts sNDA For Antiepileptic Agent Fycompa as Adjunctive Treatment of Primary Generalized Tonic-Clonic Seizures  Individual.com15 hours ago U.S. FDA Grants Priority Review Status to NDA for Anticancer Agent Lenvatinib  Drugs.com9 hours ago
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Reuters

US FDA backs abuse deterrent labeling for Pfizer's Embeda ER

The US Food and Drug Administration has approved an updated label for pharma giant Pfizer's (NYSE: PFE) Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies.
 Pharma Letter1 day ago Stock Update (NYSE:PFE): FDA panel votes to keep severe warning on Pfizer anti-smoking drug  Pettinga Financial Advisors4 days ago FDA panel votes to keep severe warning on Pfizer anti-smoking drug  Reuters4 days ago FDA Decides Black Box Warning Should Stay On Pfizers Anti-Smoking Drug  Bidness Etc4 days ago
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Reuters

Roche's Esbriet Gets US FDA Nod for IPF Treatment

Roche announced that the US Food and Drug Administration (FDA) has approved Esbriet (pirfenidone) as a treatment for idiopathic pulmonary fibrosis (IPF) in the United States. IPF is a fatal disease caused by progressive scarring (fibrosis) of the ...
 PharmaAsia1 day ago Roche receives US FDA approval for Esbriet to treat idiopathic pulmonary fibrosis  PharmaBiz4 days ago Roche says US approves Avastin drug to treat cervical cancer  Reuters2 months ago New Inhaled Drug Accredited to Treat Chronic Obstructive Pulmonary Disease  Med India2 months ago

Genentech's IPF-treating drug Esbriet receives FDA approval

Roche Group subsidiary Genentech has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) drug to treat patients with idiopathic pulmonary fibrosis (IPF). Esbriet is an oral medicine believed to interfere with the ...
 Pharmaceutical Technology4 days ago US FDA approves Genentech's Esbriet and Boehringer Ingelheim's Ofev for IPF  Pharma Letter5 days ago
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