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About 1139 results for "us food drug administration"

Sun Pharma to Ask US Regulator for Halol Reinspection in March Quarter

Sun Pharma to Ask US Regulator for Halol Reinspection in March...

New Delhi : Drug major Sun PharmaceuticalIndustries may ask the US Food and Drug Administration (FDA)in the firstquarter of next fiscal year for reinspection of its Halol facilityas it undertakes remediation measures to make the plantcompliant to ... NDTV, 1 day ago

311 images for us food drug administration

Times of India, 1 week ago
Business Standard, 5 days ago
BioSpace, 1 week ago
CNN, 1 day ago
Business Insider, 3 days ago
Reuters UK, 3 days ago, 3 days ago
Epoch Times, 5 days ago
Daily Caller, 3 weeks ago
BDlive, 1 week ago

Taro provides cushion for Sun Pharma

For Sun Pharmaceutical Industries, concerns on its Halol Plant, which is under the US Food and Drug Administration (USFDA) scanner, had led to benign expectations for the December 2015 quarter. Thus, a beat on profitability saw the stock rise 2.1 ...
 Smart Investor21 hours ago US FDA letter warns Sun Pharma on quality, methods  Economic Times1 month ago Shares of India's Biggest Drugmaker Sink on US 'Warning Letter'  NDTV1 month ago Fresh Halol hitch for Sun Pharma  The Telegraph1 month ago

ONL Therapeutics gets FDA orphan drug designation for ONL1204 to treat retinal detachment

The US Food and Drug Administration (FDA) has granted orphan drug designation to ONL Therapeutics' ONL1204 for the treatment of retinal detachment. ONL1204 is a novel, first-in-class small molecule peptide designed to protect key retinal cells, ...
 Pharmaceutical Business Review1 day ago Endonovo Therapeutics Retains Holland & Knight to File for Orphan Drug Designation  Bloomberg2 days ago CIDARA THERAPEUTICS : Receives Orphan Drug Designation for Novel Echinocandin, CU101 IV, in Candidemia and Invasive Candidiasis  4 Traders3 days ago Cidara's antifungal drug, CD101 IV receives US FDA orphan drug status  PharmaBiz1 day ago
Business Standard India

Mylan launches generic seizure drug i...

The news comes after Mylan received US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) on 11 January 2016. Felbamate tablets are recommended for monotherapy or adjunctive therapy in the treatment of ...
 GaBi Online1 day ago Lannett passes US FDA approval for chemotherapy agent Temozolomide  Bloomberg1 day ago Aurobindo gets US FDA nod for anti-infective injection  Smart Investor2 days ago LUPIN EXPECTS TO END YEAR WITH MORE US APPROVALS; NET PROFIT ON RECOVERY PATH  Pharmacy Choice5 days ago

Becton, Dickinson receives US FDA nod for diagnostic device for HIV/AIDS

Becton, Dickinson and Company (BD), a leading global medical technology company, has received US Food and Drug Administration (FDA) 510(k) clearance for its BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge. The BD FACSPresto system is an ...
 PharmaBiz1 day ago Spectranetics passes US FDA 510(k) clearance for the cardiac life-saving technology Bridge Occlusion Balloon  Bloomberg4 days ago BD wins US FDA approval for BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge for HIV/AIDS test  Bloomberg2 days ago

Pharmaceutical drugs: call for uniform regulatory standards

This will sustain both pharmaceutical industry and regulatory agencies A senior official of the US Food and Drug Administration has underscored the need for uniform regulatory standards for pharmaceutical drugs. Participating in a panel ...
 The Hindu1 day ago
The Telegraph

US FDA points to loose quality controls, data deletions at Zydus Cadila’s two facilities

MUMBAI: A recent warning letter issued by the US Food and Drug Administration to Cadila Healthcare's Moraiya facility points to failures in standard operating procedures, one of which notably is to "thoroughly investigate unexplained discrepancy and failure ...
 Economic Times1 month ago Will resolve issues raised by USFDA in a timely manner: DRL  Business Standard4 days ago Zydus Cadila gets USFDA warning  Times of India1 month ago Quality rap on Cadila Healthcare  The Telegraph1 month ago

US FDA committee recommends approval of Celltrion's biosimilar mAb medication CT-P13 for all eligible indications

Celltrion, a global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all eligible indications for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s ...
 PharmaBiz2 days ago FDA panel recommends approval for copy of arthritis drug Remicade  4 Traders2 days ago FDA advisory panel strongly backs biosimilar Remicade  Reuters4 days ago FDA panel recommends approval of Teva's biotech asthma drug  Economic Times2 months ago

US FDA imposes partial hold on CTI BioPharma's pacritinib clinical trial

CTI BioPharma Corp, a biopharmaceutical company, announced that it received written communication from the US Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studies being ...
 PharmaBiz4 days ago Matinas BioPharma gets US patent for novel lipid-crystal nano-particle cochleate formulation technology  PharmaBiz17 hours ago
Reuters UK

FDA halts clinical trial of CTI Biopharma's blood cancer drug

The US Food and Drug Administration has put a complete hold on CTI Biopharma's new blood cancer drug Pacritinib. The hold comes as a result of the deaths that have occurred during the experimental trial. Patients have reportedly died of cardiac ...
 Pharmaceutical Business Review2 days ago FDA puts full clinical hold on CTI BioPharma's blood cancer drug  Yahoo! India3 days ago FDA lifts clinical hold on Advaxis' cancer compounds  Reuters1 month ago
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