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About 1178 results for "us food and drug administration"

FDA expanded use of eye drug
CNBC

FDA Oks expanded use of Regeneron's eye drug

Reuters (Reuters) - Regeneron Pharmaceuticals Inc said the U.S. Food and Drug Administration has approved the expanded use of its eye drug Eylea for the treatment of diabetic macular edema. The condition causes swelling of an oval spot within ... Yahoo! India, 5 hours ago
FDA expanded use of eye drug CNBC, 1 hour ago
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1,788 images for us food and drug administration

Baltimore Sun, 5 days ago
Orlando Sentinel, 5 days ago
Med India, 2 weeks ago
Orlando Sentinel, 1 week ago
92.9 WLMI, 3 weeks ago
Yahoo! News, 5 days ago
Reuters India, 5 days ago
Daily Caller, 4 weeks ago
Reuters India, 1 week ago
Elyria Chronicle Telegram, 4 days ago
Rediff.com

FDA reveals details on generic drugs watchdog reorganization

The U.S. Food and Drug Administration (FDA) has announced details of its long-awaited reorganization of the Office of Generic Drugs (OGD) . The latest update to the reforms regarding the regulator mostly affects appointments to leadership positions.
 Processing Magazine10 hours ago Strides Arcolab Gets US Regulatory Nod to Sell Transplant Drug  NDTV Profit6 days ago US FDA India head quits; regulator goes for rejig  Rediff.com1 week ago Strides Arcolab gets USFDA approval to sell transplant drug  Business Standard India6 days ago
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Pharma Letter

US FDA approves Imbruvica for chronic lymphocytic leukemia

CLL is a rare blood and bone marrow disease that usually gets worse slowly over time The US Food and Drug Administration (US FDA) expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who ...
 Express Pharma21 hours ago U.S. FDA Grants Regular (Full) Approval for Pharmacyclics Inc's IMBRUVICA for two indications  Reuters1 day ago J&J -IMBRUVICA (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p  Town Hall17 hours ago US FDA grants approval for Imbruvica for chronic lymphocytic leukemia  Pharma Letter17 hours ago
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Bioniche Life Sciences Inc announces submission of Orphan Drug Designation Application for MCNA in United States

Bioniche Life Sciences Inc:Submission to the US Food and Drug Administration (FDA) Office of Orphan Products Development.Says an application for Orphan Drug Designation for its Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile suspension ...
 Reuters15 hours ago Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States  Barchart16 hours ago Bioniche Life Sciences Inc. Announces Submission Of Orphan Drug Designation Application For MCNA In The United States  BioSpace11 hours ago Bioniche submits orphan-drug-designation app for MCNA  Stockwatch16 hours ago
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Pozen Updates on FDA Acceptance of Refiling of New Drug Application for PA8140/PA32540 Tablets [Professional Services Close - Up]

Pozen reported that the U.S. Food and Drug Administration (FDA) has accepted for review, the resubmission of the New Drug Application (NDA) for PA8140/PA32540. According to a company release, the FDA also indicated the NDA would be treated as a ...
 Pharmacy Choice2 days ago FDA Accepts for Review Adamis' New Drug Application for Its Epinephrine Pre-Filled Syringe  Individual.com15 hours ago FDA Accepts For Review Adamis Pharmaceuticals' New Drug Application For Its Epinephrine Pre-Filled Syringe  BioSpace7 hours ago ADAMIS PHARMACEUTICALS : FDA Accepts for Review Adamis' New Drug Application for Its Epinephrine Pre-Filled Syringe  4 Traders15 hours ago
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U.S. FDA raises concerns about Impax's Taiwanese plant

July 29 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued "certain observations" after an inspection of the company's manufacturing plant in Taiwan. The regulator issued a ten observations in a Form 483, which ...
 CNBC16 hours ago Impax Parkinson's drug future shaky as FDA flags factory issues  Reuters15 hours ago UPDATE 2-Impax Parkinson's drug future shaky as FDA flags factory issues  Reuters10 hours ago
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Quidel passes US FDA's clearance to market molecular diagnostic test AmpliVue assay for Group A Strep

Diagnostic testing company Quidel (NASDAQ:QDEL) disclosed on Monday the receipt of the US Food and Drug Administration's (FDA) approval to market its AmpliVue GAS Assay for the qualitative detection of Group A ?-hemolytic Streptococcus ...
 Individual.com17 hours ago

Food Freedom Fest Celebrates Local Food Hero

The Food and Drug Administration (FDA), under the Food Safety Modernization Act (FSMA), is trying to control all food regulation and poses a threat to the local food movement. The September gathering is a meeting of people who see the benefit of ...
 Morningstar.com10 hours ago
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MedCity News

AcelRx stock plunges 40% after FDA rejects pain drug device

NEW YORK: Shares of AcelRx Pharmaceuticals Inc plunged almost 40 percent after the U.S. Food and Drug Administration rejected its pain treatment late on Friday. The rejection also reduces the lead the drug device, Zalviso, was likely to have over a ...
 TheStar.com.my1 day ago AcelRx stock plunges after FDA rejects pain drug device  CNBC1 day ago Rejected (for now): FDA wants more info on AcelRx's pain relief drug delivery device  MedCity News1 day ago FDA Wants More Info on AcelRx Pain Drug Device Zalviso  Diabetes Care7 hours ago
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Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE(TM) (doxycycline hyclate USP) Tablets, 150 mg and 75 mg

WEST CHESTER, Pa.--(BUSINESS WIRE)-- West Chester-based Aqua Pharmaceuticals, an Almirall company, today announces the U.S. Food and Drug Administration (FDA) approval of the NDA for ACTICLATE (doxycycline hyclate USP) Tablets, 150 mg and 75 mg, ...
 CNBC1 day ago U.S. Food and Drug Administration keurt Zydelig® (idelalisib) van Gilead goed voor recidiverende chronische lymfocytische leukemie, folliculair lymfoom en klein lymfocytisch lymfoom  Business Wire4 days ago U.S. Food and Drug Administration lässt Zydelig® (Idelalisib) von Gilead für Rezidive von chronischer lymphozytischer Leukämie, follikulärem Lymphom und kleinzelligem B-Zellen-Lymphom zu  Business Wire4 days ago U.S. Food and Drug Administration Approves Gilead's Zydelig® (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma  CNBC6 days ago
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