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Biotech/Pharma - Regulatory
DSM Sinochem Pharmaceuticals Supports Fight Against Superbugs And Welcomes The Clear Recommendations Of The AMR Review 5/24/2016
BIO Release: Arizona Governor Ducey Signs Bill Ensuring Patient Access To Interchangeable Biologic Medicines 5/24/2016
Warwick Analytical 24 Hour ICP Analysis Service 5/23/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For Four PCR-Based Assays 5/23/2016
Intoxalock is Now Certified To Install Ignition Interlock Devices In Florida 5/23/2016
Oxitec CEO To Testify Before Congressional Committee On May 25th 5/23/2016
California Life Sciences Association Release: Patients, Life Sciences Community Announce Opposition To SB 1010; Launch Digital Campaign 5/23/2016
FDA More Than Doubles the Number of Orphan Drug Designation Revocations Overnight 5/20/2016
Why is Congress Trying to Weaken the FDA's Oversight of Dangerous Drugs? 5/19/2016
Ampronix, Manufacturer Of Medical Touch Screens And Innovative Technology, Is Fully ISO 9001 And ISO 13485 Certified - Leaders Within The Medical Industry 5/19/2016
CytoSorbents Release: CytoSorb Achieves Final Product Registration In Russia 5/18/2016
Roche (RHHBY) Submits 510 (K) Filing To FDA For Treponema Pallidum Assay To Aid Clinicians In The Diagnosis Of Syphilis Infection 5/18/2016
Valeant (VRX) Provides Update Regarding Regulatory Matters 5/17/2016
Health Canada To Propose Regulatory Change To Enable Consideration Of Applications Under The Special Access Programme To Facilitate Treatment Of Chronic Relapsing Opioid Dependence 5/16/2016
Lupus Research Institute Release: New $5 Million Lupus Medical Research Program Approved By House Subcommittee 5/16/2016
International Trade Commission To Investigate Chinese Manufacturer BMC Medical's Infringement Of ResMed (RMD) Patents 5/13/2016
Centene Corporation's Florida Subsidiary Awarded Accreditation From NCQA 5/13/2016
B.Braun Medical Execs Unhappy Over What They Say is a Lack of Protocol at ECRI Institute 5/13/2016
Why An FDA Plan To Find Compassionate-Use Drugs May Be A Band-Aid 5/13/2016
WuXi AppTec's Pharmaceutical Development Service And Analytical Service Passes European Medicines Agency Inspection 5/12/2016
FDA Grapples With Gray Areas In Fast-Tracking Experimental Drugs 5/11/2016
Lungpacer Medical, Inc. Receives Expedited Access Pathway Designation From FDA For The Lungpacer Diaphragm Pacing System 5/11/2016
Kitov (KTOV) Reports KIT-302 Study Successfully Meets FDA Bioequivalence Standards 5/10/2016
Is FDA Evidence Sufficient To Corroborate Allegations That Theranos Violated Medical Device Regulations? 5/10/2016
BioElectronics Corporation Responds To U.S. FDA's Comments On Its Market Clearance Application 5/10/2016
MGB Biopharma Limited's Pre-IND Meeting With FDA Provides Clear Guidelines On Further Development Of Oral MGB-BP-3, A Truly Novel Antibiotic Targeting Clostridium Difficile Infections 5/9/2016
ImmunoCellular Therapeutics, Ltd (IMUC) Receives Regulatory Approval In Canada, The UK And The Netherlands To Initiate ICT-107 Phase 3 Trial In Newly Diagnosed Glioblastoma 5/6/2016
Ukeru Systems Submit Comments To The FDA On The Need To Immediately Ban The Use Of Electrical Stimulation Devices 5/6/2016
Valeant (VRX) Announces Patient Access And Pricing Committee To Oversee Pricing Of Drugs 5/6/2016
Bionical Outlines New Approach To Partner With Healthcare And Pharmaceutical Industry 5/6/2016
Betting Intensifies Over Sarepta (SRPT)’s DMD Drug 5/6/2016
RSC Bio Solutions' Envirologic 3068 And Envirologic 3100 High Performance Hydraulic Fluids Approved For Use In Man Diesel & Turbo Stern Tubes And Propellers 5/5/2016
FDA Takes Significant Steps To Protect Americans From Dangers Of Tobacco Through New Regulation 5/5/2016
Orthocell Receives Ethics Approval For Collagen Scaffold Study 5/4/2016
ImmunID Receives CLIA Certification From The US Centers For Medicare & Medicaid Services 5/3/2016
Zika Test From Quest Diagnostics (DGX) Authorized By The FDA For Emergency Use 4/29/2016
Exemplar Genetics Release: Game-Changing Animal Research Models Offer Superior Translational Research And Better Predictive Efficacy 4/27/2016
Rounding Up the Experts’ Thoughts on What's Next for Sarepta (SRPT)'s DMD Drug 4/27/2016
Thermal Gradient Enters Commercial Prototype Testing Phase 4/26/2016
Muscular Dystrophy Association Chief Medical And Scientific Officer Testifies At Landmark FDA Hearing For Duchenne Drug 4/26/2016
Air Cargo Community Frankfurt e.V. Release: Airfreight: Frankfurt Is Becoming Europe's Largest Certified Pharma-Hub 4/25/2016
BIO Release: CSRxP Plan Fails To Tackle Real Drivers Of Consumer Out Of Pocket Costs 4/25/2016
Austrianova Facility Commissioned For GMP Manufacturing 4/25/2016
ValGenesis, Inc. Successfully Completes Iso 9001:2008 Surveillance Audit 4/22/2016
AFter FDA Rejection, TransEnterix (TRXC) Could Turn Focus to Other Surgery Robot 4/22/2016
The American Urological Association's Quality Registry Certified By CMS As A Qualified Clinical Data Registry 4/21/2016
Smithers Avanza Adds CLIA Certification To Provide Further Support For Clients’ Clinical Trials 4/21/2016
DermTech Receives CAP Accreditation 4/20/2016
LifeSci Advisors Announces Comprehensive Action Plan To Advance Gender Diversity In The Life Sciences Industry 4/20/2016
NantOmics Receives Certification From The Centers For Medicare And Medicaid Services And Accreditation From The College of American Pathologists 4/19/2016
Feds Propose Banning Theranos CEO Elizabeth Holmes from the Blood Testing Biz for at Least Two Years 4/18/2016
FDA Release: Three New Draft Guidances Related To Compounding Of Human Drugs 4/18/2016
ACT Genomics Receives CAP Accreditation, Offering Full-Scale And Comprehensive Clinical Services To Transform Cancer Care 4/18/2016
RedHill Biopharma (RDHL) Announces Positive FDA Meeting On RHB-105 Path To Approval And Planned Confirmatory Phase III Study For H. Pylori Infection 4/18/2016
ESMO Welcomes Final Version Of European General Data Protection Regulation 4/15/2016
Valeant (VRX) Provides Update Regarding Regulatory Matters 4/14/2016
California Life Sciences Association Statement On SB 1010 4/14/2016
Imprimis (immy) Registers Its Texas Facility With The FDA As An Outsourcing Facility 4/12/2016
Renovacare Completes Engineering, Research, And Studies Required To File 510(K) Submission To The FDA For Its Novel Medical-Grade Liquid Spray Device 4/12/2016
OWC Pharmaceutical Research Corp. Comments On Israel's Proposed Medical Cannabis Guidelines 4/12/2016
Appili Receives Orphan Drug Designation From FDA For ATI-1501 4/12/2016
Quantex Laboratories Awarded ISO/IEC 17025:2005 Accreditation 4/12/2016
WuXi AppTec Lab Testing Division's Analytical And Stability Testing Facilities Passed FDA Inspection 4/11/2016
Royal DSM’s Dyneema Purity Fibers Meet Revised ASTM F2848-16 Material Specifications For Medical-Grade UHMWPE Yarns 4/11/2016
FDA Takes Steps To Withdraw Approval Of The Swine Drug Carbadox Due To Safety Concerns 4/11/2016
TapImmune (TPIV) Completes GMP Manufacturing And Release Of TPIV 200 Vaccine 4/7/2016
Toshiba America Medical Systems's Aplio Platinum Series Ultrasound Authorized As Secure By U.S. Department Of Defense 4/7/2016
PURE Bioscience (PURE) Receives USDA Permission Letter To Begin In-Plant Poultry Processing Trial Using SDC-Based PURE Control Antimicrobial 4/7/2016
Prime Therapeutics Statement On FDA's Approval Of Biosimilar Inflectra 4/6/2016
Ortho Kinematics Becomes ISO 13485-Certified And Clears FDA Audit 4/6/2016
Mevion Medical Systems Brings Proton Therapy To Central Florida 4/6/2016
American Optometric Association Complaint Urges FDA Enforcement Of Device Standards On Vision "App" 4/5/2016
SELLAS Life Sciences Group Receives A Favorable Opinion For European Orphan Drug Designations For WT1 Cancer Vaccine (galinpepimut-S) For The Treatment Of Acute Myeloid Leukemia And For Malignant Pleural Mesothelioma 4/5/2016
Valeant (VRX) Ad Hoc Committee Announces Completion Of Its Review Of Philidor And Related Accounting Matters 4/5/2016
Massachusetts Biotech Companies Debate Innovative Pricing Structures for Transformative Medicines 4/4/2016
Freshloc Technologies Releases Fast Budget Check-Up Tool For Healthcare Supply Chain To Quote Regulatory Compliance For Temperature Monitoring 4/1/2016
New 2016 American College of Cardiology/AHA Guideline Focused Update States That It Is Reasonable To Choose Effient (Prasugrel) Over Clopidogrel For Certain ACS-PCI Patients With ST-Elevation Myocardial Infarction And NSTE-ACS 3/31/2016
FDA Allows Use Of Investigational Test To Screen Blood Donations For Zika Virus 3/31/2016
Roche (RHHBY) To Initiate Testing For Zika Virus At U.S. Blood Centres Under FDA Investigational New Drug Application Protocol 3/31/2016
European Medicines Agency Validates Bristol-Myers Squibb (BMY)'s Application For Opdivo (Nivolumab) For The Treatment Of Classical Hodgkin Lymphoma Patients 3/31/2016
FDA's Big Task: Stop The Next Martin Shkreli and Valeant (VRX) 3/30/2016
Paragon BioTeck Receives EN ISO 13485:2012 Certification 3/29/2016
Quest Diagnostics (DGX) Marlborough Lab Earns LEED Green Building Certification 3/29/2016
California Life Sciences Association Releases New Infographic Detailing Improved FDA Drug Review Performance 3/29/2016
Envigo's Horst Facility Earns AAALAC Accreditation 3/29/2016
FDA Scorns Eagle Pharma (EGRX)'s Seven Year Orphan Drug Exclusivity Request for Blood Cancer Drug BENDEKA 3/28/2016
TransEnterix Says FDA Isn't Finished Reviewing SurgiBot Application 3/25/2016
Mezzion (140410.KQ) Receives Special Protocol Assessment (SPA) Agreement From FDA For Udenafil Phase 3 Studies In Adolescents With Single Ventricle Congenital Heart Disease With Fontan Physiology 3/24/2016
Aesica Comments On API Manufacturing Trends 3/24/2016
Carestream Health Submits Application For FDA 510(K) Clearance For Its Onsight 3D Extremity System 3/24/2016
BioCorp: Announces Eligibility PEA-SME For 2016/2017 3/24/2016
Centene Corporation And Health Net, Inc. Receive CDI Regulatory Approval 3/23/2016
Cytori Therapeutics (CYTX) Granted SME Status By European Medicines Agency 3/23/2016
Freshloc Technologies Launches Tool To Quote Compliance With CDC Guidelines For Temperature Monitoring 3/22/2016
Centene Corporation And Health Net Receive DMHC Regulatory Approval 3/22/2016
WHO Issues Positive Recommendation For Oxitec's Self-Limiting Mosquito 3/21/2016
Immunetics, Inc. BacTx Test Helps Hospitals Meet FDA Proposed Changes in Platelet Bacteria Testing Practices 3/21/2016
Fabre Kramer Pharmaceuticals, Inc. Release: FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder 3/18/2016
FDA Makes One Small Regulatory Change in Effort to Stop the Next Martin Shkreli 3/17/2016
Cleveland Biolabs Inc. (CBLI) Provides Update On Pre-EUA Review Of Entolimod As Radiation Countermeasure 3/17/2016
Pivot Pharmaceuticals Announces Blue Sky Compliance 3/16/2016
Cerus (CERS) Announces The Inclusion Of Pathogen Reduction Technology In FDA’s Revised Guidance Document On Bacterial Safety Standards For Platelets 3/15/2016
Toro Management, LLC DBA SYLK Announces That Its Product SYLK Has Received Its FDA 510(K) Clearance As A Class II Medical Device 3/14/2016
Barrow Neurological Institute Becomes First In The Nation To Receive Joint Commission Certification For The Treatment Of Both Traumatic Brain Injury And Spinal Cord Injury 3/11/2016
Natera Release: American Medical Association Grants New CPT Code For Microdeletion Testing 3/11/2016
Allergan (AGN) Receives Complete Response Letter From FDA For Prior Approval Supplement For RESTASIS (Cyclosporine Ophthalmic Emulsion) 0.05% Multi-Dose Preservative-Free Bottle 3/10/2016
UL Provides Medical Device Manufacturers Alternative To Traditional CFDA Testing 3/10/2016
Pharmaceutical Research and Manufacturers of America (PhRMA) Releases New Policy Solutions For Delivering Innovative Treatments To Patients 3/10/2016
Mass. Start-up Interscope Receives European Regulatory Approval, Secures Five U.S. Patents For Medical Devices Innovation 3/10/2016
Royal Philips Electronics N.V. (PHG) Meets Stringent U.S. Government Security Requirements For Pathology Medical Data 3/10/2016
Arch Therapeutics Receives ISO 13485 Certification For AC5 3/10/2016
Innovus Pharma Announces The Filing Of The Product License To Commercialize Androferti With Health Canada 3/9/2016
Whistle-Blower Of Unsafe Medicines Takes On "Made In India" 3/8/2016
Inari Medical Announces IDE Approval To Study The FlowTriever System For The Treatment Of Pulmonary Embolism 3/8/2016
Cellect Announces Receipt Of IRB Approval To Conduct Its Clinical Trial In Leukemia Patients 3/7/2016
Corvia Medical Receives IDE Approval For REDUCE LAP-HF I Clinical Study & Announces Agreement With Strategic Partner For Exclusive Option To Purchase Company 3/7/2016
IBBR Request For Proposals (RFP) - GMP Bio-Manufacturing Facility Available 3/7/2016
Solos Endoscopy, Inc. (SLSE.PK) FDA Establishment Registration & Device Listing Renewed For 2016 3/3/2016
WIRB-Copernicus Group Helps Develop Ethics Tool Kit For Clinical Research Protocols; Resulting Product Published In Journal Of Medical Ethics 3/2/2016
RSSL Puts The Focus On Cleaning 3/2/2016
Sartorius Stedim Biotech BioOutsource Contract Testing Facility in Glasgow Successfully Passes FDA Inspection 3/2/2016
MiMedx Supports FDA's Decision To Postpone April 13th Hearing On Draft Guidance Documents 3/1/2016
Bedfont Scientific Responds to FDA's Decision to Temporarily Detain Its Products 3/1/2016
InVivo Therapeutics (NVIV) Announces FDA Acceptance Of A Modular Submission And Review Process For The Neuro-Spinal Scaffold 3/1/2016
Olympus Corporation Of The Americas And Subsidiary Reach Settlement Agreements With U.S. Department Of Justice 3/1/2016
Health Canada Issues Notice Of Compliance For Gilead (GILD)'s Truvada For Reducing The Risk Of Sexually Acquired HIV Infection 2/29/2016
XYMOGEN Earns Prestigious Australian TGA Certification 2/25/2016
Firstkind, A Sky Medical Technology Company, Is Delighted To Announce RCN Accreditation Of Its User Training Programme For The geko Device For VTE Prevention 2/25/2016
tesa Labtec GmbH Announces Successful Completion Of FDA Pre-Approval Inspections Of Its R&D And Manufacturing Facilities 2/24/2016
Luminex (LMNX) Receives Medical Device License For ARIES System And ARIES HSV 1&2 Assay In Canada 2/23/2016
American Association for Clinical Chemistry Calls For Modernization Of Regulatory Framework For Clinical Labs 2/23/2016
BioConnected Licenses Valencell's PerformTek Sensor Technology To Bring Next-Gen "Smart" Earphones To Market 2/23/2016
TiGenix Obtains Commercial Production License For Cx601 2/23/2016
McKesson Corporation Lab Earns 2015/2016 Best In KLAS Recognition 2/23/2016
Horizon Pharma (HZNP) Announces That Health Canada Determines RAVICTI (Glycerol Phenylbutyrate) Oral Liquid Is Eligible For Data Protection 2/23/2016
Thousands Of Goats And Rabbits Vanish From Major Biotech Lab 2/22/2016
Rosetta Genomics (ROSG) Receives Approval From New York State For First-Of-Its-Kind Thyroid Cancer Diagnostic Assay 2/18/2016
Ceres, Inc. Receives Positive Response from USDA Regarding Corn Traits 2/17/2016
Evana Automation Launches New Validation Program To Assist Healthcare Product Manufacturers With Meeting FDA Regulations During The Implementation Of Automated Manufacturing Equipment 2/17/2016
Neogen Corporation (NEOG)'s ANSR For Listeria Receives AFNOR Validation 2/16/2016
New National Comprehensive Cancer Network Guidelines Include Evidence Blocks To Illustrate Value In Breast, Colon, Kidney, And Rectal Cancers 2/12/2016
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



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