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About 821 results for "us food drug administration"

USFDA warns of Dr Reddy's drug import ban if flaws are not fixed
Financial Express

US FDA extends 2 weeks deadline for Dr. Reddy's response on qu...

The United States Food and Drugs Administration (USFDA), which had issued a 15 days deadline to respond to its warning letters issued to Dr. Reddy's laboratories has extended it to 2 weeks more till December 7. With USFDA issued warnings to 3 ... PharmaBiz, 2 hours ago
US drug cop warns DRL of import ban Calcutta Telegraph, 1 day ago

FDA finalizes genetically engineered food labeling guidance & approves AquAdvantage Salmon

Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for use as human food ...
 Lexology34 minutes ago US Approves Genetically-modified Salmon  Asia hours ago Food for Thought: FDA Approves Genetically Engineered Salmon  JD Supra2 days ago US approves GM salmon for food  BBC1 week ago

Lysogene Receives Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA

Lysogene, a leading, gene therapy clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation and rare pediatric disease designation to LYS-SAF-302, a potential treatment ...
 CPhI.cn1 day ago Merck KGaA, Darmstadt, Germany, And Pfizer Receive Positive Opinion For Orphan Drug Designation For Avelumab In Merkel Cell Carcinoma From EMA Committee For Orphan Medicinal Products  TheStreet.com2 days ago Aduro Biotech Receives Orphan Drug Designation in the European Union for CRS-207 for the Treatment of Mesothelioma  Pharmacy Choice3 days ago Germany : Merck and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan... [TendersInfo (India)]  Pharmacy Choice2 hours ago

US FDA warns of serious data integrity violations at DRL

The US Food and Drug Administration has warned DRL over serious data integrity violations, placing all its new applications or supplements under a cloud The US Food and Drug Administration (US FDA) has warned Dr Reddy's Laboratories (DRL) over ...
 Financial Express1 day ago

FDA Alerts On Compounded Vitamin Capsules Distributed By Glades Drugs

The U.S. Food and Drug Administration has alerted health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in ...
 RTTNews.com1 day ago Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol)  U.S. Food and Drug Administration1 day ago

DRL kept us in dark on lab: FDA

Hyderabad : In the most damaging observation against Dr Reddy's Laboratories (DRL), the US Food and Drug Administration (FDA) has accused the Hyderabad-based drug maker of keeping it dark about the use and existance of an uncontrolled laboratory at ...
 Deccan Chronicle1 day ago US Regulator Gives Dr Reddy's Additional Time to Respond to Warning Letter  MyInforms1 day ago

US FDA approves first seasonal influenza vaccine containing adjuvant, Fluad

The US Food and Drug Administration (FDA) has approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the ...
 PharmaBiz1 day ago US FDA approves Seqirus flu vaccine Fluad  Pharma Letter1 day ago US okays stronger seasonal flu vaccine for elderly  Hong Kong Standard Finance1 day ago

Market Update: Bristol-Myers Squibb Company (NYSE:BMY) FDA approves expanded use of Bristol-Myers skin cancer drug

at 07:31 AM EST [Reuters] Bristol-Myers Squibb Co said the U.S. Food and Drug Administration had approved the expanded use of its cancer drug, Opdivo, to treat an additional form of advanced skin cancer. The company . . . → Read More: Market ...
 MoneyShow.com2 days ago Expanded Use of Advanced Skin Cancer Drug Receives FDA Approval  HT Syndication1 day ago FDA approves expanded use of Bristol-Myers' skin cancer drug  Sharenet3 days ago Food and drug administration grants genetically designed fish Oneida Dispatch  NewsListOnline5 days ago

US FDA approves new indication for BioThrax vaccine for use after known or suspected anthrax exposure

The US Food and Drug Administration (FDA) approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine's ...
 PharmaBiz1 day ago

BioMarin DMD Drug Data Not Persuasive Enough: FDA

A panel of outside advisers to the U.S. Food and Drug Administration indicated that efficacy data from BioMarin Pharmaceutical Inc (BMRN.O) on its experimental drug for treating a muscle wastage disorder was not persuasive enough to warrant approval ...
 MedIndia2 days ago FDA panel: BioMarin muscle wastage drug data not persuasive  Reuters UK2 days ago FDA panel: BioMarin DMD drug data not persuasive enough  Yahoo! Finance2 days ago UPDATE 2-FDA panel says BioMarin DMD drug data not persuasive enough  Reuters UK2 days ago
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