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About 971 results for "us food and drug administration"

New Indication for Empagliflozin
HCPLive

FDA Approves Empagliflozin for Reducing CVD Death

The US Food and Drug Administration (FDA) has approved empagliflozin ( Jardiance , Boehringer Ingelheim Pharmaceuticals Inc) for the new indication of improving survival in adults with type 2 diabetes and cardiovascular disease (CVD). The sodium ... Dermatology Online Journal, 20 hours ago
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Money Control

Lupin receives US FDA nod for sleep disorder drug armodafinil [Seven Days (United Arab Emirates)]

The US Food and Drug Administration (FDA) has granted its final approval for Lupin Ltds armodafinil tablet (in strengthens of 50 mg, 150 mg, 200 mg and 250 mg), which is used for treating sleep disorder. The company had filed the application for the ...
 Pharmacy Choice20 hours ago FDA Adds Seven More Substances to its Inventory of Effective FCS Notifications  National Law Review1 day ago NATCO GETS US FDA NOD FOR ARMODAFINIL TABLETS  Pharmacy Choice2 days ago Natco Pharma gets USFDA nod for Armodafinil tablets  Money Control4 days ago
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Reuters

FDA OKs Diabetes Drug to Reduce Heart Risk

The U.S Food and Drug Administration said on Friday it would allow Eli Lilly and Co to state that its diabetes drug Jardiance reduces the risk of death from heart problems, potentially boosting the drug's sales. Jardiance, also known as ...
 HealthMediciNet.com17 hours ago FDA Investigates Link to Acute Pancreatitis in SGLT2 Diabetes Drugs  Drug Watch18 hours ago FDA allows use of diabetes drug Jardiance to reduce heart risk  Sharenet1 day ago Lilly's diabetes drug Jardiance cuts risk of cardiovascular death: FDA  Sharenet1 day ago
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BrightWater's ConvertX Nephroureteral Stent System receives US FDA nod to treat ureteral obstructions

BrightWater Medical, Inc. announced that the US Food and Drug Administration (FDA) has cleared the company's innovative ConvertX Nephroureteral Stent System for treatment of ureteral obstructions. Patients with obstructions preventing urine in the ...
 PharmaBiz1 day ago Samsung Showcases FDA-cleared GM85 Mobile DR System at RSNA 2016  Imaging Technology News19 hours ago FDA approves BrightWater Medical's ConvertX nephroureteral stent system  Medical Devices Business Review2 days ago Allergan Receives FDA Clearance for New Surgical Treatment for Refractory Glaucoma  Eyesmart2 days ago
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Food Safety Magazine

FDA Clears Air on Menu Labeling Compliance

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has issued a statement "clarifying" that the compliance deadline for the menu labeling rule still went into effect Thursday, Dec. 1, and not May 5, 2017, which is when enforcement will ...
 Convenience Store News1 day ago Restaurant menu labeling took effect Dec. 1, and then it did not  Before It's News13 hours ago Dec. 1 Deadline Arrives: Calorie-Labeling Compliance Is Now Mandatory For Vending Machines  Vending Times1 day ago FDA clarifies menu labeling compliance date  Institute of Food Technologists2 days ago

US FDA accepts for review Otsuka's sNDA to expand labeling of Abilify Maintena to treat bipolar I disorder

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announced the US Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena for the maintenance treatment of ...
 PharmaBiz1 day ago U.S. FDA accepts for review a supplemental New Drug Application to expand labeling of Abilify Maintena® (aripiprazole) for the treatment of Bipolar I disorder  PharmiWeb3 days ago FDA ACCEPTS FOR REVIEW A SUPPLEMENTAL NEW DRUG APPLICATION TO EXPAND LABELING OF ABILIFY MAINTENA (aripiprazole) FOR THE TREATMENT OF BIPOLAR I DISORDER  Pharmacy Choice1 day ago Otsuka Pharma Release: FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena (Aripiprazole) For The Treatment Of Bipolar I Disorder  BioSpace3 days ago
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Ready-to-Eat Food Market: Global Industry Analysis and Opportunity Assessment, 2016-2026

LONDON, Dec. 1, 2016 /PRNewswire/ -- The Food and Drug Administration (FDA) defines ready-to-eat food as animal or plant derived food that is cooked, frozen, washed, cooked for hot holding, cooled, and processed to be consumed directly or after ...
 Yahoo! Finance1 day ago
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BioSpace

Shire Release: Topline Results Of Phase 3 Investigational Study Of VONVENDI [Von Willebrand Factor (Recombinant)] Meets Primary Endpoint Effectively Controlling Bleeding And Blood Loss During Surgical Procedures

/PRNewswire/ -- Results will form the basis of a supplemental new drug application to the U.S. Food & Drug Administration, requesting an expanded indication for VONVENDI Shire plc (LSE: SHP, NASDAQ: SHPG ), the leading biotechnology company ...
 BioSpace1 day ago AbbVie's risankizumab secures FDA orphan drug status for paediatric Crohn's  Pharmaceutical Business Review2 days ago AbbVie Receives Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab from the U.S. Food and Drug Administration for the Treatment of Pediatric Patients with Crohn's Disease  TickerTech.com3 days ago MonoSol Rx Receives FDA Orphan Drug Designation for Diazepam Buccal Soluble Film to Treat Acute Repetitive Seizures  Pharmacy Choice2 days ago
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Money Today

Vivimed Labs closes 8% higher post USFDA inspection at Alathur facility

The company's 'Finished Dosage Form' manufacturing facility has had a favourable outcome post its US Food and Drug Administration (USFDA) inspection, Vivimed Labs said in a filing to BSE. The audit was conducted during the last week of November and concluded ...
 Money Today3 days ago Vivimed Labs Alathur unit completes successful USFDA visit  Money Control4 days ago
Money Control

Panacea Biotec receives EIR from USFDA for Baddi facilities

The company has received EIR from the US Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and pre-approval inspection conducted at its oncology parenteral and oral solids dosage formulation facilities at Baddi, Panacea Biotec ...
 Money Control1 week ago Alembic Pharma receives EIR report from USFDA  Money Control1 month ago
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