UDENT FDA News

Dec14 FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection
Created by UDENT News on 12/14/2008 10:47:01 PM

Eisai Corporation of North America today announced that the U.S. Food and Drug Administration (FD...
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Feb03 Galderma Wins FDA Approval for Vectical(TM) Ointment
Created by UDENT News on 2/3/2009 1:08:17 PM

Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has ap...
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Feb06 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
Created by UDENT News on 2/6/2009 9:45:14 PM

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the c...
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Feb09 ARKRAY USA Receives FDA Clearance on GLUCOCARD(R) 01-mini Blood Glucose Monitoring System
Created by UDENT News on 2/9/2009 3:27:45 PM

ARKRAY USA, Inc., the 5th largest Blood Glucose Monitoring Company in the world, announced 510(k) c...
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Feb09 FDA Fails to Protect Public: Remains Silent About Lead in Lipstick
Created by UDENT News on 2/9/2009 9:42:40 PM

More than a year after the Campaign for Safe Cosmetics reported that popular brands of lipstick con...
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Feb25 Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold(TM) Technology for Soft Tissue Repair
Created by UDENT News on 2/25/2009 10:08:19 AM

Serica Technologies, Inc., a growth-stage medical device company developing silk-based biomaterial ...
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Mar04 FDA Clears New Skin and Surface Treatment Applicator for Use With Xoft's Axxent(R) Electronic Brachytherapy (eBx) System
Created by UDENT News on 3/4/2009 9:35:53 AM

Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration...
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Mar11 Female Health Company Receives FDA Approval for FC2 Female Condom(R)
Created by UDENT News on 3/11/2009 9:31:52 AM

The Female Health Company (NYSE Alternext: FHC) today announced approval from the U.S. Food and Dru...
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Mar05 Ranbaxy Secures Final FDA Approval for Quinapril Hydrochloride + Hydrochlorothiazide Tablets
Created by UDENT News on 3/5/2009 9:34:12 AM

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL)...
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Mar18 U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent
Created by UDENT News on 3/18/2009 12:16:47 PM

IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minim...
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Mar23 FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression
Created by UDENT News on 3/23/2009 11:26:16 AM

The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax(R) (olanzapin...
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Mar26 Physician Group Opposes FDA's Position on Adult Stem Cells
Created by UDENT News on 3/26/2009 1:28:40 PM

The American Stem Cell Therapy Association (ASCTA) is formed in response to the Food and Drug Admi...
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Mar27 Sagent Pharmaceuticals Announces U.S. FDA Approval of Azithromycin for Injection
Created by UDENT News on 3/27/2009 9:41:42 AM

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced U...
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Apr01 GSK Submits TYVERB(R)/TYKERB(R) (lapatinib) for First-Line Treatment of Metastatic Breast Cancer in Europe, US
Created by UDENT News on 4/1/2009 1:52:20 PM

GlaxoSmithKline (NYSE: GSK) today announced the submission of two simultaneous regulatory applicati...
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Apr03 FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site
Created by UDENT News on 4/3/2009 10:16:48 AM

AstraZeneca is aware that earlier today, the US Food and Drug Administration (FDA) posted to its web...
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Apr09 Patient Movement Forms in Opposition to FDA Position that the Patient's Own Stem Cells are Drugs
Created by UDENT News on 4/9/2009 11:49:00 AM

A patient movement, called Safe Stem Cells NOW! was formed in response to the FDA's position that th...
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Apr14 Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
Created by UDENT News on 4/14/2009 11:40:00 AM

Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of P...
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Apr16 Vion Pharmaceuticals' New Drug Application for Onrigin(TM)Accepted For Review by the FDA
Created by UDENT News on 4/16/2009 9:11:00 AM

Vion Pharmaceuticals, Inc. (OTC Bulletin Board: VION) today announced that the New Drug Application ...
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Apr20 Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by the FDA for Hair Growth
Created by UDENT News on 4/20/2009 5:44:00 PM

Study provides clinical efficacy of the HairMax LaserComb in the treatment of Androgenetic Alopecia ...
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Apr22 FDA Grants Ethicon Endo-Surgery Approval of Its IDE Application to Commence Study of Notes Toolbox(TM)
Created by UDENT News on 4/22/2009 9:53:00 AM

Ethicon Endo-Surgery today announced that the U.S. Food and Drug Administration (FDA) granted approv...
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More FDA News
Earlier FDA News Headlines
FDA Grants Orphan Drug Designation to Gunagratinib for Cholangiocarcinoma - OncLive
FDA Approves a Nasal Antihistamine for Nonprescription Use | FDA - FDA.gov
Sen. Marshall calls on FDA to prioritize COVID-19 immune response - WIBW
Fake Fertility Supplement FTC/FDA Warning Letters - The National Law Review
The use of external controls in FDA regulatory decision making - UC Berkeley Public Health - UC Berkeley School of Public Health
Applied Therapeutics Gets Fast Track Designation from FDA - TheStreet
Remanufacturing of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff - FDA.gov
FDA Grants Priority Review to Bastilimab for Recurrent or Metastatic Cervical Cancer - www.oncnursingnews.com/
FDA Tackles Training, Recruiting in Next Phase of Data Strategy - GovernmentCIO Media & Research
FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery | FDA - FDA.gov
FDA In Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices | FDA - FDA.gov
FDA issues guidance for measuring PROs in oncology studies - OutSourcing-Pharma.com
FDA Approves Blueprint Medicine's Ayvakit for Advanced Systemic Mastocytosis - Precision Oncology News
Immunobridging still feasible, FDA says - 台北時報
Novartis experimental prostate cancer drug gets FDA breakthrough designation - Fox News
The FDA is in desperate need of some soul-searching - The Washington Post
Don't hold your breath waiting for FDA nominee; A priority review for another Bristol Myers partner - Endpoints News
FDA approves StrataGraft for thermal burns - Healio
Sanofi Facility for Flu Vaccine Licensed by FDA - BioPharm International
High-ly Sensitive Information: Use of FDA’s DMF Process to Protect Cannabis Trade Secrets - Trade Secrets Trends