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About 1225 results for "fda"

Spectranetics passes US FDA 510(k) clearance for the cardiac l...

Medical devices company Spectranetics Corporation (NasdaqGS:SPNC) revealed on Monday that it has received US Food and Drug Administration (FDA) Premarket Notification 510(k) clearance for its Bridge Occlusion Balloon for the safety, stability and ... Bloomberg, 21 minutes ago
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1,529 images for fda

BioPharma-Reporter.com, 58 minutes ago
MassDevice, 13 hours ago
Fox28 WSJV, 16 hours ago
Fox28 WSJV, 16 hours ago
Fox28 WSJV, 16 hours ago
International Business Times India, 23 minutes ago
Sci-Tech Today, 17 hours ago
WWLP.com, 18 hours ago
Whole Foods Magazine, 18 hours ago
Broadway World, 5 hours ago

Epizyme passes US FDA orphan drug status for tazemetostat for treatment of malignant rhabdoid tumors (MRTs)

Biopharmaceutical company Epizyme (NasdaqGS:EPZM) revealed on Monday that it has received US Food and Drug Administration (FDA) orphan drug status for its first-in-class EZH2 inhibitor, tazemetostat, for the treatment of malignant rhabdoid tumors ...
 Bloomberg1 hour ago Spinal Cord Injury Treatment Receives FDA Orphan Drug Designation  Rehab Manegement5 hours ago Epizyme Announces Tazemetostat Granted Orphan Drug Designation for Malignant Rhabdoid Tumors by U.S. FDA  Digital Journal22 hours ago US FDA grants Orphan Drug status to Asterias Biotherapeutics' AST-OPC1 to treat acute spinal cord injury  PharmaBiz3 days ago
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Injectable migraine treatment gets FDA approval

Injectable migraine treatment, ZEMBRACESymTouch (sumatriptan succinate) by Dr Reddy's Laboratories, has received US Food and Drug Administration (FDA) approval ZEMBRACESymTouch is an injectable, a drug-device combination product intended for the ...
 European Pharmaceutical Manufacturer8 minutes ago Dr Reddy gets approval for psoriasis drug from US FDA  United News of India1 day ago FDA drug approvals  American Nurse Today3 days ago FDA approvals to boost Dr. Reddy's prospects in US: Nomura  Business Standard6 days ago
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Zacks.com

BRISTOL MYERS SQUIBB : receives approval from US FDA for Daklinza hepatitis C treatment

Bristol-Myers Squibb, a global biopharmaceutical company, has received approval from the US Food and Drug Administration for its hepatitis drug, Daklinza (daclatasvir), an NS5A replication complex inhibitor for expanded use, it was reported ...
 4 Traders2 hours ago Bristol-Myers' Daklinza-Sovaldi Label Expanded by the FDA  Zacks.com14 hours ago FDA approves Bristol Myers Squibb's Daklinza's for expanded use to treat patients with hepatitis C  Pharmaceutical Business Review20 hours ago Bristol-Myers Squibb receives approval from US FDA for Daklinza hepatitis C treatment  Bloomberg2 hours ago
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HCPLive

FDA clears Dr. Reddy's betamethasone spray for psoriasis

The FDA clears Promius Pharma's Sernivo (betamethasone dipropionate) Spray, 0.05%, a topical steroid for the treatment of adults with mild-to-moderate plaque psoriasis. The commercial launch will commence next quarter. Promius is the U.S. wholly ...
 Seeking Alpha17 hours ago Promius' Sernivo Spray gets FDA approval to treat moderate plaque psoriasis  Pharmaceutical Technology22 hours ago Dr.Reddy's gets FDA nod for anti-psoriasis spray [Mint, New Delhi]  Bloomberg1 day ago Dr. Reddy's Says Sernivo Spray 0.05% For Plaque Psoriasis Gets FDA Approval  RTTNews.com1 day ago
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Libya News Today

Sarepta says FDA delays decision on muscle-wasting disorder drug

Feb 8 Sarepta Therapeutics Inc said the U.S. Food and Drug Administration had delayed a decision on its lead drug for a rare muscle-wasting disorder. The FDA has delayed the decision to May 26 from late February, the company said. The drug is ...
 Reuters22 hours ago Sarepta faces another FDA delay with its much-scrutinized DMD drug  FierceBiotech21 hours ago Now, get drug license online within 30 days: FDA  Times of India1 week ago FDA delays decision on Heron's nausea drug  Reuters3 weeks ago
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Nasdaq

FDA places clinical studies of CTI Bio's lead product candidate on partial clinical hold due to excess mortality; shares drop 27% premarket

Micro cap CTI BioPharma (NASDAQ: CTIC ) is down27%premarket on average volume in response to its announcement that the FDA has placed clinical studies of lead product candidate pacritinib on partial clinical hold due to excess mortality and other ...
 Seeking Alpha23 hours ago FDA places partial hold on CTI BioPharma studies  MoneyShow.com11 hours ago Baxalta drops, CTI nosedives after patient deaths & adverse events prompt FDA partial hold  BioPharma Dive19 hours ago 2/8/16 - FDA Approves Eisai's Halaven® eribulin mesylate Injection for the Treatment of Patients with Advanced Liposarcoma  Pharmacy Choice21 hours ago
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Pharmafile

FDA Acknowledges Receipt Of Resubmission Of Shire's New Drug App

Lexington, MA /PRNewswire/ - New FDA action date of July 22, 2016 Lifitegrast has the potential to be the only product approved in the U.S. in the past decade indicated for the treatment of signs and symptoms of dry eye disease in adults Shire ...
 Bioresearch Online18 hours ago FDA to decide on Shire blockbuster hopeful  Pharmafile1 day ago FDA acknowledges receipt of Shire's resubmitted NDA for lifitegrast  Orthopedics Today3 days ago Shire's self-described blockbuster eye drug lines up for FDA do-over  FierceBiotech3 days ago
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MassDevice

MEDTRONIC : FDA Approves First MR-Conditional CRT-D Devices

Release date- 08022016 - Medtronic announced Friday that FDA has approved the the first MR-conditional cardiac resynchronization therapy defibrillators (CRT-Ds) for the treatment of heart failure in the U.S. The Medtronic Amplia MRI Quad CRT-D ...
 4 Traders1 hour ago FDA approves Medtronic's MRI conditional CRT defibrillators for heart failure patients  Cardiovascular Business17 hours ago Medtronic brings home FDA approval for MRI conditional CRT-D technology  Medical Device Daily22 hours ago Medtronic gets FDA approval for MRI-safe defibrillators  Equities.com7 hours ago
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Examiner.com

FDA to make sweeping review of opioids policies

A box of the overdose antidote Naloxone Hydrochloride sits on a counter at a Walgreens store. Dr. Robert Califf, the FDA's Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, have called for a far-reaching action ...
 Examiner.com11 hours ago FDA Officials Call for Review of Agency's Opioid Policies  PT Community15 hours ago FDA makes sweeping changes for opioids  Formulary Journal18 hours ago Changing course: A new approach to opioid pain medication at FDA  Pharmacist.com19 hours ago
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