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About 1182 results for "us food and drug administration"

US regulator fast-tracks approval for Wockhardt drugs
Rediff.com

US regulator fast-tracks approval for Wockhardt drugs

Mumbai-based Wockhardt Ltd has received Qualified Infectious Disease Product (QIDP) status from the US Food and Drug Administration (FDA) for two of its drugs, WCK 771 and WCK 2349. WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet, under anti-infective category. The drugs were also granted five-year extension to the drug patents in the US. A QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment and are ... Rediff.com, 1 day ago
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468 images for us food and drug administration

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CNN, 3 weeks ago
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CBC, 2 weeks ago

Mylan's Glatiramer Acetate Injection 40 mg/ml MS ANDA filed with the US FDA

Pharmaceutical company Mylan (NasdaqGS:MYL) said on Thursday that the US Food and Drug Administration (FDA) has filed its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/ml. The company added ...
 Individual.com4 days ago Natco Pharma`s partner Mylan files ANDA for Copaxone  Myiris1 day ago Natco Pharma at record high; partner Mylan files ANDA  Money Control1 day ago Natco jumps after Mylan files ANDA for Copaxone  Myiris1 day ago
Bio Spectrum Asia

FDA notifies mandals on prasad quality

To keep incidents of food poisoning at bay, the Food and Drug Administration (FDA) has this Ganesh festival issued a circular listing regulations and precautions to be followed by mandals across Maharashtra while preparing prasad for devotees. It is now ...
 Asian Age2 days ago FDA approves pediatric use of Protalix drug  Haaretz2 days ago US FDA approves GSK's asthma drug  Bio Spectrum Asia4 days ago Pfizer seeks US FDA approval for its new drug  Bio Spectrum Asia4 days ago
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Bio Spectrum Asia

US FDA approves Strides' anti-anxiety drug

Singapore: Indian drugmaker,Strides Arcolab, has announced that it has received approval from the United States Food and Drug Administration (US FDA) for its generic drug, Buspirone Hydrochloride tablets. The tablets are used for the treatment of ...
 Bio Spectrum Asia5 days ago Zydus gets USFDA nod for anti-hypertensive drug  Hindu Business Line4 days ago Strides Arcolab : TO SELL ANTI-ANXIETY DRUG  4 Traders5 days ago Strides Arcolab receives US FDA approval for Buspirone tabs  Express Pharma6 days ago
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Health Canal

US FDA approves Elelyso for injection for paediatric indication to treat type 1 Gaucher disease

Pfizer Inc. and biopharmaceutical company, Protalix BioTherapeutics, Inc. announced that the US Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa) for injection for paediatric patients. Elelyso is therefore now indicated for ...
 PharmaBiz3 days ago US approval gives SynCardia control over heart manufacture  Performance Materials Net2 days ago FDA approves U-M-invented drug for Gaucher disease  Health Canal1 week ago US FDA approves new drug to treat Type 1 Gaucher disease in adults  PharmaBiz1 week ago
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Pfizer's investigational C. difficile vaccine candidate wins US FDA's Fast Track designation

Science health company Pfizer (NYSE:PFE) reported on Thursday the receipt of the US Food and Drug Administration's (FDA) Fast Track designation for its investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). The company ...
 Individual.com4 days ago Pfizer's Investigational Vaccine Candidate for Clostridium difficile Receives U.S. Food and Drug Administration Fast Track Designation  Market Pulse Navigator5 days ago Pfizer : Investigational Vaccine Candidate for Clostridium difficile Receives U.S. Food and Drug Administration Fast Track Designation  4 Traders4 days ago
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US FDA grants priority review status for ivabradine to treat chronic heart failure

Amgen, a multinational biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that ...
 PharmaBiz5 days ago Amgen Gets FDA Priority Review For Heart Drug - Update  RTTNews.com6 days ago Amgen's NDA for heart failure drug ivabradine gets FDA priority review status  Pharmaceutical Business Review5 days ago Amgens NDA for heart failure drug ivabradine gets FDA priority review status  Big News Network5 days ago
Boston Globe

Alkermes seeks US FDA approval for aripiprazole lauroxil to treat schizophrenia

Alkermes plc, a global biopharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of aripiprazole lauroxil, the company's investigational, novel, once-monthly, long-acting ...
 PharmaBiz6 days ago Alkermes submits NDA to FDA for schizophrenia drug aripiprazole lauroxil  Pharmaceutical Business Review1 week ago Alkermes Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia  Stock Nod1 week ago Alkermes submits application for schizophrenia drug  Boston Globe1 week ago
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Reuters

OncoMed says FDA lifts partial hold on cancer drug trials

Aug 28 (Reuters) - OncoMed Pharmaceuticals Inc said the U.S. Food and Drug Administration lifted a partial hold on patient enrolments for three trials testing its experimental cancer drug, vantictumab. Enrolment of new patients is expected to ...
 CNBC5 days ago OncoMed to resume enrollment in cancer drug trials as FDA lifts partial ban  MedCity News5 days ago FDA Lifts Partial Hold on OncoMed's Cancer Drug Trials  Medscape4 days ago UPDATE 1-FDA lifts partial hold on OncoMed's cancer drug trials  Reuters UK5 days ago
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Jutia Group

Amgen submits U.S. application to sell cholesterol-fighting drug

Aug 28 (Reuters) - Amgen Inc said it submitted an application to the U.S. Food and Drug Administration to market its cholesterol-lowering drug, evolocumab. The injectable drug works by blocking PCSK9, a naturally occurring protein that keeps ...
 Yahoo! Finance5 days ago Amgen submits PCSK9 inhibitor cholesterol drug to FDA for approval  MedCity News5 days ago Company Update: Amgen Inc (NASDAQ:AMGN) Amgen submits U.S. application to sell cholesterol-fighting drug  TVNewsCheck5 days ago Amgen seeks U.S. approval of new cholesterol-fighting drug  Yahoo! News5 days ago
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