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Biotech/Pharma - Regulatory
Eagle Analytical Services Achieves ISO/IEC 17025 Accreditation, The Single Most Important Standard For Calibration And Testing Laboratories Around The World 2/11/2016
Pfizer (PFE) Commends The FDA Advisory Committee’s Vote To Approve Proposed Biosimilar Infliximab, The First Biosimilar Monoclonal Antibody Reviewed, For All Eligible Indications 2/10/2016
FDA’s Arthritis Advisory Committee Recommends Approval Of Celltrion (068270.KQ)’s CT-P13, A Proposed Biosimilar Infliximab, For All Indications 2/10/2016
NeoChord Again Awarded NUB Status 1 In Germany 2/10/2016
Bluestar Silicones Achieves ISO 8 And ISO 7 Clean Room Certification; Promotes Long-Term Implant Offering At MD&M West 2/9/2016
Parenteral Drug Association Publishes First-Of-Its-Kind Comparison Of Sterile Processing GMPs 2/9/2016
Admera Health Receives CLIA Approval For Its Breakthrough Liquid Biopsy Testing Platform 2/9/2016
Eurofins Food Safety Systems Introduces FSSC 22000 Certification Audits 2/9/2016
Angel Medical Systems Announces FDA Advisory Committee Meeting For Review Of The Angelmed Guardian System 2/8/2016
Cartiva Announces Tentative Date Of FDA Advisory Panel Review Of Cartiva SCI 2/8/2016
PharmaMar S.A. Release: The Phase III Clinical Trial Using PM1183 In Treating Ovarian Cancer (CORAIL) Continues Following The IDMC's Positive Recommendation 2/8/2016
Vizient, Inc. Endorses The FDA’s Biosimilars Approval Pathway 2/8/2016
Califf, FDA Top Officials Call For Sweeping Review Of Agency Opioids Policies 2/5/2016
Amarantus BioSciences Requests Rare Pediatric Disease Designation From US FDA For MANF In The Treatment Of Retinitis Pigmentosa 2/5/2016
Takeda (TKPYY) Release: FDA Psychopharmacologic Drug Advisory Committee Supports the Effectiveness of Brintellix (vortioxetine) in Treating Certain Aspects of Cognitive Dysfunction in Major Depressive Disorder (MDD) 2/4/2016
SMTC’s Dongguan, China Facility Awarded ISO 13485 Certification For Medical Devices 2/2/2016
Telesta (TSX:TST) Receives Complete Response Letter From FDA 2/2/2016
Intersect ENT Announces NUB Status 1 Designation For PROPEL Sinus Implant In Germany 1/29/2016
Veracyte (VCYT) Receives Regulatory Authorization To Offer Percepta Bronchial Genomic Classifier For Patients In New York State 1/28/2016
Sinovac Biotech Ltd. (SVA) Announces Issuance Of GMP Certificate For EV71 Vaccine 1/28/2016
Cynata Receives Favourable Advice From UK Regulatory Authority 1/28/2016
Cardiome Pharma Corp. (COM.TO) Announces Filing Of Orphan Drug Application For Oral Vernakalant With U.S. FDA 1/27/2016
Meridian Laboratories Announces Positive Outcome From Pre-NDA Meeting With FDA For ML141 1/27/2016
BioLineRx Ltd. Receives Confirmation Of Medical Device Classification In Europe For Celiac Treatment 1/25/2016
Centene Corporation's Arkansas Subsidiary Awarded Accreditation From NCQA 1/21/2016
Courtagen Receives New York State Clinical Laboratory Approval 1/21/2016
Congenica Achieves ISO 27001 And NHS IGT Accreditation 1/18/2016
Zecotek Photonics Inc. Granted U.S. Notice Of Allowance For Enhanced LFS Crystal Array Manufacturing 1/15/2016
PDP Couriers Achieves WDA Licence 1/15/2016
BioAmber Inc. Sarnia Certified To ISO 9001, ISO 14001, OHSAS 18001 And FSSC 22000 1/14/2016
New Senate Report Says FDA Fails to Make Sure Medical Devices are Safe 1/14/2016
Intouch Solutions Certified As Level Four Veeva Systems, Inc. Multichannel Content Partner 1/13/2016
Olympus (OCPNF) Releases Statement In Response To US Senate HELP Committee Report 1/13/2016
Epic Sciences Receives CAP Accreditation 1/11/2016
AMRI (AMRI) Announces First Product Approval Out Of Its Massachusetts Aseptic Fill Finish Site 1/11/2016
Claritas Genomics Awarded International Organization For Standardization (ISO) Accreditation For Molecular Diagnostic Testing From The American Association For Laboratory Accreditation (A2LA) 1/7/2016
MiMedx Receives Certificate From FDA Allowing The Export Of MiMedx Allografts 1/6/2016
NovoCure Files Premarket Approval Supplement Application With FDA For Second Generation Optune System 1/6/2016
Sinovac Biotech Ltd. (SVA) Obtains New Drug Certificate And Production License For EV71 Vaccine 1/4/2016
Novation Announces Product Categories For Period 1 National Group Buys Program 1/4/2016
Orchid Pharma Stock Surges on U.S. FDA Inspection Report for TN Unit 12/31/2015
Orchid Pharma Stock Surges On U.S. FDA Inspection Report For TN Unit 12/31/2015
Amarantus BioSciences, Inc. Requests Rare Pediatric Disease And Orphan Drug Designations From US FDA For Engineered Skin Substitute In The Treatment Of Giant Congenital Melanocytic Nevi 12/29/2015
Materialise Receives FDA NSE Letter for X-Ray 510(k) Submission 12/22/2015
CytoSorbents, Inc. Issues EAP Update 12/22/2015
Amarantus Provides Update On cGMP Manufacturing Validation For The Engineered Skin Substitute (ESS) Program 12/22/2015
Jennewein Biotechnologie GmbH’s Conclusion That Its 2’-Fucosyllactose Is GRAS For Use In Infant Formula And Toddler Nutrition Is Accepted By U.S. FDA 12/22/2015
SunPharm (SUNP) Slumps After U.S. FDA Warning for Halol Plant 12/21/2015
Neurelis Receives FDA Orphan Drug Designation For NRL-1 In The Treatment Of Acute Repetitive Seizures 12/21/2015
CAPNIA, Inc. Granted Orphan Designation For Nasal CO2 For The Treatment Of Trigeminal Neuralgia 12/21/2015
Sarepta (SRPT) Announces FDA Advisory Committee Meeting To Review Eteplirsen As A Treatment For Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 12/18/2015
TWi Pharmaceuticals, Inc. Receives Favorable Decision From The U.S. Court Of Appeals For The Federal Circuit Regarding TWi's Generic Version Of MEGACE ES 625mg/5ml 12/16/2015
AMP Responds To FDA Report On Oversight Of Laboratory Developed Testing Procedures 12/16/2015
BeiGene Selects GE Healthcare’s FlexFactory Biomanufacturing Platform For Pilot cGMP Production Facility In China 12/16/2015
TissueGen, Inc.'s New ISO Class 7 Facility Supports FDA cGMP Drug Product Manufacturing 12/16/2015
Pharmaron LLC Receives A CFDA GLP Certificate For Its Safety Assessment Facility 12/16/2015
Clontech Laboratories, Inc. Earns ISO 13485:2003 Certification 12/14/2015
CTD Holdings, Inc.' Clinical Trial Design Receives Positive Responses From U.K.'s Medicines And Healthcare Products Regulatory Agency 12/14/2015
Avita Medical Release: FDA Grants ReCell Expedited Access Pathway Designation 12/14/2015
CombiMatrix (CBMX)'s Array For Pre-Implantation Genetic Screening Granted Conditional Approval From New York State Department Of Health 12/10/2015
Biopharma Services Inc. - Three Inspections, Two Sites, One Company, Zero 483’s! 12/10/2015
Anika Therapeutics (ANIK) Announces Decision To Proceed With CINGAL Premarket Review Through FDA’s Center For Drug Evaluation And Research 12/10/2015
Spectranetics (SPNC) Announces FDA Submission Of Bridge Occlusion Balloon For Lead Extraction Procedures 12/9/2015
Vericel (ASTM) Submits HDE Supplement To The FDA To Revise The Labeled Indications For Use And Add Pediatric Labeling For Epicel 12/8/2015
Diagnomics And Maverix Biomics Achieve CLIA Validation For Clinical Diagnostic Pre-Natal Testing 12/8/2015
Health Canada Issues Notice Of Compliance For Gilead (GILD)’s Single Tabletregimen Genvoya (Elvitegravir, Cobicistat, Emtricitabine And Tenofoviralafenamide) For Treatment Of HIV-1 Infection 12/7/2015
GE Healthcare Life Sciences Strengthens Business Resilience With ISO 22301 Business Continuity Accreditation For Chromatography Media 12/3/2015
Guided Therapeutics And FDA Review Team Agree On Path Forward For Luviva® Advanced Cervical Scan PMA Application 12/2/2015
Vetter Receives Internationally Recognized AEO-F Certificate For Global Movement Of Goods 12/1/2015
Puma Biotech (PBYI) Provides Update From Meeting With European Medicines Agency 12/1/2015
Solvay Epicerol Earns Roundtable On Sustainable Biomaterials Certification 12/1/2015
Epigenomics AG Appeals Recent FDA Request For Additional Information 11/30/2015
MetaStat Receives CLIA Certification From The Centers for Medicare & Medicaid Services 11/30/2015
SkylineDx Receives CE-IVD Mark For MMprofiler -- Its Innovative Gene Signature-Based Test For Multiple Myeloma 11/25/2015
Medibio’s Study With Johns Hopkins University School of Medicine Receives IRB Approval 11/24/2015
ADM Tronics (ADMT) Withdraws FDA App for Angiodroid CO2 Injector for Angiography 11/23/2015
Ash Stevens Approved As The API Manufacturer For Ixazomib Citrate 11/23/2015
CFDA Issues New Drug/Clinical Trial Approval Regulations 11/20/2015
Hikma (HIK.L) Announces Successful Resolution To FDA Warning Letter At Its Portugal Facility 11/18/2015
Anavex (AVXL) Announces Preparation Of Regulatory Filings Based On Guidance From FDA 11/18/2015
Enzo Biochem (ENZ) Announces New York State Approval Of Its First Assay Based On Ampiprobetm Platform Aimed At Providing Affordable Molecular Diagnostics In Light Of Reimbursement Pressure 11/17/2015
Symphony Clinical Research Earns WBENC-Certified Women’s Business Enterprise Distinction For Second Consecutive Year 11/17/2015
Diatherix Receives Accreditation From College of American Pathologists 11/16/2015
Stock Slides as Boston Scientific (BSX)'s Watchman Hit by Restrictive CMS Coverage Decision 11/12/2015
Opko Health (OPK) 4Kscore Test Receives Category I CPT Code Approval 11/12/2015
Amedica Corporation Submits 24-Month Clinical Data To FDA For Clearance Of Composite Interbody Spinal Device 11/11/2015
NeuroMetrix (NURO)’ Quell Wearable Pain Relief Device Receives American Podiatric Medical Association (APMA) Seal Of Approval 11/11/2015
ScinoPharm Changshu Site Completed US FDA Inspection 11/9/2015
Alere (ALR)'s SD BIOLINE HIV/Syphilis Duo Is First Dual Test To Receive WHO Prequalification 11/9/2015
PTS Diagnostics ' Patent Enforcement Against Jant Pharmacal Gains Momentum 11/6/2015
Albright Technologies Completes ISO 13485:2003 Certification Audit 11/6/2015
FDA Requests Further Data For Approval Of Epigenomics AG' Blood Based Colorectal Cancer Screening Test 11/5/2015
European Medicines Agency Validates Bristol-Myers Squibb (BMY)’s Type II Variation Application For Opdivo (Nivolumab) In Previously Treated Advanced Renal Cell Carcinoma 11/5/2015
FDA Draft Guidance May Have Caught MiMedx Off-Guard 11/4/2015
ALung Receives Expedited Access Pathway Designation From FDA For Hemolung Respiratory Assist System 11/4/2015
NovImmune SA's New Rheumatoid Arthritis Drug Clears Regulatory Hurdles 11/3/2015
NovImmune SA’s New Rheumatoid Arthritis Drug Clears Regulatory Hurdles 11/2/2015
China Cord Blood Corporation Guangdong Subsidiary Has Been Accredited By American Association Of Blood Banks 10/30/2015
BioPharm Executive: From Bad to Worse: Biotech's Next Political Headache? 10/29/2015
Sientra (SIEN) Provides Business Update 10/29/2015
Imprimis (immy) Announces Plans To Register Its Texas Pharmacy With The FDA As An Outsourcing Facility 10/29/2015
EDP Biotech Achieves ISO 13485 Certification 10/28/2015
Bavarian Nordic (BAVA.CO) Announces Expansion Of IMVAMUNE Orders From Canadian Government 10/28/2015
Cynosure (CYNO) Receives Health Canada Authorization To Market MonaLisa Touch For Genitourinary Syndrome Of Menopause 10/28/2015
InDevR Receives ISO 13485:2003 Certification For Assays, Instrumentation And IVD Products 10/27/2015
Amsel Medical Announces Filing Of 2nd 510(K) Pre-Marketing Notification With The US Food And Drug Administration For The Amsel Occluder Device 10/27/2015
PixarBio Corporation Announces FDA OPD Submission Of Neurorelease TN For Orphan Drug Designation For Trigeminal Neuralgia 10/26/2015
SHINE Medical Technologies Achieves Major Milestone On Path To Construction Permit Approval 10/26/2015
Cartiva Announces GMP Certification By Brazil's ANVISA 10/26/2015
Bio-Techne (TECH) Certifies Over 1,000 Antibodies For Simple Western 10/26/2015
TSO3 Allowed Expanded Claims For Revolutionary STERIZONE VP4 Sterilizer 10/26/2015
Theranos Continues to Battle Wall Street Journal Critics, Says FDA Made Unannounced Inspections 10/23/2015
AGTC (AGTC) Announces Orphan Drug Designation In The European Union For Gene Therapy To Treat Achromatopsia 10/22/2015
Would Washington’s FDA Fix Cure Patients Or The Drug Industry? 10/21/2015
goBalto, Inc. Release: New European Clinical Trial Regulations Aim To Reduce Administrative Burden And Costs 10/21/2015
China Biologic Products Received Operating Permit For New Branch Collection Facility In Shandong Province 10/20/2015
Gaumard Scientific's Latest UNI Operating System Is Compliant with Newly Released 2015 AHA CPR/ECC Guidelines 10/19/2015
EDAP TMS S.A. (EDAP) Direct De Novo For Ablatherm HIFU Replaced By 510(K) 10/16/2015
Kapa Biosystems Earns ISO 13485:2003 Certification 10/15/2015
Alere (ALR) Receives U.S. HHS Approval To Electronically Process Drug Tests For Department Of Transportation-Regulated Employees 10/15/2015
Redwood Scientific Technologies Announces TBX-FREE Completes FDA Registration 10/14/2015
Gensignia Receives CLIA Certification Of Its San Diego Laboratory 10/13/2015
Thermo Fisher Scientific (TMO) Manufacturing Site First In Forensic Industry To Meet Proposed Guidelines For ISO 18385 Certification 10/13/2015
TearLab (TEAR) Release: Medical Necessity Of Tear Osmolarity Testing In The Diagnosis And Management Of Dry Eye Disease Confirmed In Recently Published Medicare Local Coverage Determination 10/9/2015
Salix (SLXP) Release: FDA Grants RUCONEST (C1 Esterase Inhibitor [Recombinant]) Twelve-Year Reference Product Exclusivity 10/8/2015
AcelRx (ACRX) Provides Regulatory Update On Zalviso 10/8/2015
Avant Diagnostics Receives FDAIRB Approval for OvaDx Ovarian Cancer Validation Test Specimens 10/7/2015
Marathon Pharmaceuticals, LLC Receives Rare Pediatric Disease Designation From FDA For Deflazacort As A Potential Treatment Of Duchenne Muscular Dystrophy 10/7/2015
Akebia Therapeutics, Inc. (AKBA) Reaches Agreement With FDA And European Medicines Agency On Vadadustat Global Phase III Program 10/6/2015
Successful Australian TGA Inspection Of Asymchem's Dunhua Facility 10/5/2015
Sientra (SIEN)'s Silicon Implant Supplier in Brazil Shut Down by Regulators 10/5/2015
INC Research (INCR) Enhances Clinical Trial Efficiency Through iCardiac Site Certification 10/1/2015
FDA Sets New Regulations Affecting Entire AED Market 10/1/2015
Nordion Welcomes 10 Year Operating License Renewal 9/30/2015
Zafgen (ZFGN) Granted Orphan Drug Designation In The European Union For Beloranib, A First-In-Class Metap2 Inhibitor For The Treatment Of Craniopharyngioma 9/30/2015
Helsinn Group Awarded Global CEO Cancer Gold Standard Accreditation 9/30/2015
Telesta (TSX:TST) Announces FDA Advisory Committee Date For MCNA1 9/28/2015
Bruker Corporation’s NMR FoodScreener Laboratory Achieves ISO/IEC 17025 Accreditation 9/25/2015
Xhale Inc. Submits Biomarker Qualification Package To FDA For Medication Adherence Monitoring Tool 9/22/2015
Re-Analysis of GlaxoSmithKline (GSK)’s Seroxat/Paxil Antidepressant Data Shows Lack of Transparency 9/17/2015
CSL Limited (CMXHF.PK) Release: FDA Advisory Panel Recommends Licensure of NVS Influenza Candidate Vaccine for Protection Against Seasonal Influenza in the Elderly 9/16/2015
Marrone Bio Innovations, Inc' GRANDEVO Bioinsecticide Receives Completeness Determination From The Netherlands 9/15/2015
China Issues Rules For Approval Of Stem Cell Clinical Trials 9/11/2015
BioCision, LLC Announces FDA Master File Acceptance For Thawstar Automated Cell Thawing Instrument 9/9/2015
EndoGastric Solutions, Inc. Announces AMA Assignment Of CPT Code And Short Form Descriptor 9/9/2015
IMPAX Labs (IPXL) Announces Resolution Of FDA Warning Letter Related To Its Hayward Manufacturing Facility 9/8/2015
Mabion Begins Pre-Registration Scientific Advice With The European Medicines Agency 9/8/2015
Cynvenio Receives Accreditation From College of American Pathologists 9/8/2015
Medigus (MDGS.TA) Announces American Medical Association's Publication Of New Category I CPT Code 9/8/2015
Mesoblast (MSB.AX) Partner JCR Pharmaceuticals Receives Recommendation For Approval Of Mesenchymal Stem Cell Product In Japan 9/4/2015
Amyris, Inc. Set To Increase Global Growth Of Its Cosmetic Emollients Through ISO 22716 Certification 9/2/2015
HYD Pharma Receives GMP Certification For Deuterium-Depleted Water (DDW) Production Facility 9/2/2015
Bestronics Achieves ISO 13485 Certification 9/1/2015
Great Basin Scientific Submits 510(K) Application To The FDA For Staph ID/R Blood Culture 8/31/2015
CFDA To Start 60-Day Approvals For INDs Of Oncology Drugs 8/28/2015
WuXi PharmaTech (WX)'s STA Subsidiary Receives First Approval From Japanese Regulatory Authorities 8/27/2015
Arcadia Biosciences (RKDA) Release: Verdeca’s HB4 Stress Tolerance Trait Completes FDA Early Food Safety Evaluation 8/26/2015
EDAP TMS S.A. (EDAP) Provides Formal Response To FDA Addressing All Concerns Raised In July 2015 Ablatherm HIFU Letter 8/25/2015
InformedDNA Achieves NCQA Utilization Management Certification 8/25/2015
Sarepta (SRPT) Receives Rare Pediatric Disease Designation From FDA For Eteplirsen For The Potential Treatment Of Duchenne Muscular Dystrophy 8/21/2015
CombiMatrix (CBMX)'s Combisnp Array For Prenatal Diagnosis Test Granted Approval From New York City Department of Health and Mental Hygiene 8/18/2015
Radiant Sage Achieves ISO 9001: 2008 Quality Management System Certification 8/18/2015
PAREXEL International (PRXL) Receives CEO Cancer Gold Standard Accreditation 8/13/2015
SynteractHCR Requalifies As Certified Member Of BVMA, The Federal Association Of CROs In Germany 8/12/2015
Symbiosis Pharmaceutical Services Release: Successful Sterile Inspection For Scottish CMO 8/10/2015
COLA Accreditation Renewed For Moleculera Labs Testing Services For Childhood Autoimmune Conditions Affecting Brain And Behavior 8/6/2015
Agendia BV Release: NCCN Breast Cancer Guidelines Acknowledge MammaPrint’s Ability to Predict Prognosis 7/28/2015
IndiPharm Awarded Bionexus Status By Malaysian Biotechnology Corporation 7/28/2015
Cellular Biomedicine Group (CBMG) Announces Successful New Certifications For Proprietary Cell And Tissue Preservation Media Kits 7/27/2015
HTG Molecular Diagnostics Achieves ISO 13485:2003 Recertification 7/24/2015
Sigma-Aldrich Corporation (SIAL) Meets Evolving Quality and Regulatory Needs with ISO 13485 Expansion, Provides Diagnostic Customers with Reliable Critical Raw Materials 7/23/2015
European Medicines Agency Release: Stimulating The Development Of Medicines For Children 7/23/2015
FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim For ABSSSI 7/23/2015
Aratana Therapeutics (PETX) Provides Update On Monoclonal Antibody Products 7/22/2015
Konica Minolta Medical Imaging U.S.A, Inc. (KPI1.BE) AeroDR Achieves Compliance With FIPS 140-2 Security Standard For DoD AND VA Facilities 7/21/2015
PPD, Inc. (PPDI) Achieves CEO Cancer Gold Standard Reaccreditation 7/20/2015
NanoString (NSTG) Release: NCCN Clinical Practice Guidelines For Breast Cancer Acknowledge Prosigna/PAM50 As Clinically Validated For Prediction Of Prognosis 7/17/2015
Amerita Receives Full URAC Specialty Pharmacy Accreditation 7/17/2015
NMS Labs Earns Prestigious International Accreditation From The American Society Of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) 7/16/2015
Roka Bioscience, Inc. (ROKA) Receives AOAC Certification For The Atlas Listeria Environmental Detection Assay 7/15/2015
Vericel (ASTM) Announces Plan To Submit HDE Supplement To The FDA To Revise The Labeled Indications For Use And Add Pediatric Labeling For Epicel 7/14/2015
ASPiRA Labs Receives New York State Permit 7/13/2015
Neogen Corporation (NEOG)'s ANSR For Listeria monocytogenes Receives AOAC Approval 7/10/2015
Indian CRO Quality Questioned, As Quest Life Sciences Warned by WHO for HIV Trial Fraud 7/9/2015
Arrowhead Research Corporation (ARWR) Receives Regulatory Clearance For ARC-AAT Phase 1 In The United Kingdom And New Zealand 7/8/2015
Prima Biomed (PRR.AX) Receives Positive Scientific Advice From European Medicines Agency For Its Lead Product, IMP321 7/7/2015
Esperion Therapeutics (ESPR) Announces Removal Of 240 mg Partial Clinical Hold For ETC-1002 7/7/2015
Mauna Kea Technologies Receives Regulatory Approval For The AQ-Flex 19 Miniprobe In Japan 7/6/2015
BGI Receives Accreditation From The College of American Pathologists 7/6/2015
Innocoll, Inc. (INNL) Announces Qualified Infectious Disease Product (QIDP) Designation For Cogenzia For The Adjunctive Treatment Of Moderate And Severe Diabetic Foot Infection 6/30/2015
ImmunID Receives Accreditation From College of American Pathologists 6/30/2015
Elevance Aria WTP 40 Certified As HX-1 Food-Grade 6/30/2015
Sirona Biochem Appoints Casper Bych To Its Board of Directors 6/29/2015
Information Update - Health Canada Requests Quarantine Of Drugs Linked To Polydrug Laboratories Due To Data Integrity Concerns 6/25/2015
Beximco Pharmaceuticals Receives U.S. FDA Approval 6/24/2015
Protagen AG Achieves Significant Milestone With ISO 13485 Certification 6/24/2015
TOMI Receives EPA Registration For Its Patented BIT Technology 6/24/2015
Thermo Fisher Scientific (TMO) Release: OIE Approves Registration Of BOVIGAM TB Kit In Diagnostics Manual, Boosting Global Effort To Manage Bovine Tuberculosis 6/24/2015
Verdezyne, Inc. Earns USDA Certified Biobased Product Certification And Label 6/24/2015
Arcadia Biosciences (RKDA)’ Gamma-Linolenic Acid Safflower Meal Receives Approval From FDA For Use In Animal Feed 6/23/2015



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