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Biotech/Pharma - Regulatory
Yabao Pharmaceuticals In-licenses China Rights To Parkinson's Drug Technology 11/21/2014
National Institute for Clinical Excellence (NICE) Requests More Info On Novartis AG (NVS)'s Xolair To Treat Chronic Hives 11/20/2014
Endo Pharmaceuticals (ENDP) Announces Early Termination Of HSR Act Waiting Period In Connection With Its Proposed Acquisition Of Auxilium Pharmaceuticals (AUXL) 11/19/2014
Terumo BCT And Banco de Sangre de Servicios Mutuos Unite In A Treatment Use Program Developed To Help Improve Blood Supply Safety Using An Investigational Device 11/19/2014
FDA Puts Partial Hold On CytRx Corporation (CYTR)'s Aldoxorubicin Clinical Trials 11/19/2014
FDA Delays Final Rule On Allowing Generic Drug Makers To Update Labels 11/18/2014
TissueGene, Inc. Receives Recommendations From FDA On Pathway To Phase 3 Trial Of TG-C For Treatment Of Osteoarthritis Of The Knee 11/17/2014
Cell Source's Megadose Drug Combination Receives Regulatory Approval In Italy To Commence Human Clinical Trials 11/13/2014
U.S. FDA Sends Warning Letter To Cadila Pharmaceuticals 11/12/2014
Polyphor’s Lead Antibiotic POL7080 Receives Qualified Infectious Disease Product (QIDP) Designation From The FDA 11/12/2014
AcelRx Pharmaceuticals (ACRX) Receives International Standards Organization (ISO) 13485:2003 Certification Of Its Quality Management System 11/10/2014
Cardiome Pharma Corp. (COM.TO) Submits BRINAVESS® Reimbursement Dossier To Italian Authorities To Support Market Access 11/10/2014
Mabion: Consultation On FDA Certification 11/5/2014
Actavis (ACT) And Durata Therapeutics, Inc.  (DRTX) Receive U.S. FTC Clearance For Actavis' Proposed Acquisition Of Durata 11/3/2014
Lannett Company, Inc. (LCI) Announces Positive FDA Inspection Results 11/3/2014
Veloxis Pharmaceuticals A/S (VELO) Announces Tentative Approval Of Envarsus® XR 10/31/2014
RetroSense Therapeutics Granted Orphan Drug Designation For Lead Product RST-001 For Retinitis Pigmentosa 10/30/2014
IntelliPharmaCeutics Reports That The FDA Has Given Its Toronto Manufacturing Facility An "Acceptable" Classification 10/27/2014
Tianyin Pharmaceutical Co, Inc.'s QLF Updates On Its GMP Certification Progress 10/23/2014
Clanotech AB Receives Orphan Drug Designation In The EU 10/20/2014
U.S. Regulators Ask Three Labs For Mapp Biopharmaceutical's ZMapp Ebola Plans 10/20/2014
Health Canada Issues Notice Of Compliance For Gilead Sciences, Inc. (GILD)'s Harvoni™ (ledipasvir/sofosbuvir), The First Once-Daily Single Tablet Regimen For The Treatment Of Genotype 1 Chronic Hepatitis C 10/17/2014
China Biologic Products Receives Approval For Commercial Manufacturing Of Human Prothrombin Complex Concentrate At Shandong Taibang Facility 10/17/2014
Health Canada Release: Safety Information On The Risk Of Blood Clots With Immunoglobulin Products 10/13/2014
Nuvilex (NVLX) Applies To FDA For Orphan Drug Designation For Its Cell-In-A-Box® Treatment For Pancreatic Cancer 10/13/2014
Amgen (AMGN)'s Leukemia Drug Blinatumomab Gets FDA Priority Review 10/10/2014
Shire Pharmaceuticals Group plc (SHPGY) Provides Regulatory Update On SHP 465, Investigational Compound For ADHD In Adults 10/9/2014
Abattis Announces Zoning Approval On The Experion MMPR Application 10/8/2014
Manzo Pharmaceuticals Gets Confirmation That Lacto-Freedom Probiotic Is A Dietary Supplement And Will Not Need FDA Approval 10/7/2014
National Institute for Clinical Excellence (NICE) Rejects Another Roche (RHHBY) Leukemia Drug Citing Data Uncertainties 10/6/2014
FDA Grants Durata Therapeutics, Inc.  (DRTX) A Special Protocol Agreement (SPA) For Its Phase 3 Study Of DALVANCE(TM) In Hospitalized Community-Acquired Pneumonia 10/3/2014
Merck & Co. (MRK) Congratulates Ecuador As Second Country To Receive Pan American Health Organization/World Health Organization Verification Of Elimination Of River Blindness 10/3/2014
Rare Cancers Europe Calls For New Criteria To Be Used In Clinical Trials On Rare Cancer Treatments 10/2/2014
Information Update - Health Canada Takes Action To Stop Import Of Products From Three Sites In India 10/1/2014
Valeant Pharmaceuticals International (VRX)' Bridgewater Location Receives Warning Letter From FDA 9/30/2014
U.S. Patent and Trademark Office Issues Can-Fite BioPharma (CFBI) Patent For CF102 In The Treatment Of Liver Regeneration And Function Following Surgery 9/30/2014
Tianyin Pharmaceutical Co, Inc.'s QLF Completes GMP Site Inspection By CFDA 9/29/2014
AcelRx Pharmaceuticals (ACRX) Provides Regulatory Update On Zalviso™ 9/26/2014
Information Update - Health Canada Requests Quarantine Of Products For Canadian Market From Apotex Inc. Facility In Bangalore, India 9/25/2014
Emergency Use Of Tekmira Pharmaceuticals Corporation (TKMR)'s Ebola Drug Cleared By FDA, Health Canada 9/24/2014
Anti-Addiction Groups Call For FDA Commissioner To Step Down 9/24/2014
IMRIS Announces Waiver And Amendment Agreement And Repricing Of Warrants 9/24/2014
Medunik Canada Announces Health Canada Priority Review Of PHEBURANE® Indicated For The Treatment Of Urea Cycle Disorders (UCD) 9/24/2014
KemPharm, Inc. Receives Health Canada Approval To Begin KP201 Clinical Trials In Canada 9/23/2014
OxThera, Inc. Release: Oxabact® Granted European Medicines Agency Orphan Drug Designation For Treatment Of SBS 9/23/2014
Parenteral Drug Association Launches Effort To Harmonize Global Post-Approval Changes Protocols 9/22/2014
Natco Pharma Limited, Orchid Chemicals Hit With A Strong Dose Of FDA Medicine 9/19/2014
GlaxoSmithKline (GSK) Resolves Violation Issue At Montana Facility 9/18/2014
Spectrum Pharmaceuticals, Inc. (SPPI) Out-Licenses Rights For Greater China To CASI Pharmaceuticals  (ENMD) For Three Of Its Drugs 9/18/2014
Seward Secures Strong Environmental Credentials Through ISO14001 Certification 9/18/2014
Thermo Fisher Scientific (TMO) Announces Listing Of The Ion PGM Dx System With The U.S. FDA As Class II Medical Device 9/18/2014
ImmunoCellular Therapeutics, Ltd (IMUC) Receives Positive Regulatory Feedback On ICT-107 Supporting Advancement To Registrational Phase 3 Testing In Newly Diagnosed Glioblastoma 9/17/2014
Soligenix (SNGX) Announces FDA Clearance Of Phase 3 Clinical Protocol Of SGX301 In Cutaneous T-Cell Lymphoma 9/17/2014
Acura Pharmaceuticals, Inc. (ACUR) Submits Formal Dispute Resolution Request With FDA Regarding Hydrocodone Bitartrate With Acetaminophen Tablets 9/17/2014
FDA Panel Backs Limits On Testosterone Drugs 9/17/2014
Novartis AG (NVS), Roche (RHHBY) Cry Foul On New Swiss Pricing System 9/16/2014
Alchem International Commits To Tropane Alkaloid Apis And Extends Production And Regulatory Support To Resolve Supply Gap 9/15/2014
FDA's Surprise Visit To Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS)'s Pressures Stock 9/12/2014
Rock Creek Pharmaceuticals Receives New Dietary Ingredient Notification (NDIN) Response 9/12/2014
Tianyin Pharmaceutical Co, Inc. Release: JCM Applies For Azithromycin API Import Certificate At India 9/9/2014
Columbia Laboratories, Inc. (CBRX) Announces Completion Of CRINONE License Renewal 9/8/2014
Cleveland Biolabs Inc. (CBLI) Announces Green Light To Submit Pre-Emergency Use Authorization Application For Entolimod 9/4/2014
Ex-Researcher From Now-Dissolved Cetero Rebukes FDA Over Warning Letter 9/4/2014
Ganeden Biotech Release: USP Issues Testing Standards Monograph For GanedenBC30. 9/3/2014
Cleveland Biolabs Inc. (CBLI) To Report Outcome Of July FDA Meeting And Host Conference Call On September 3 9/3/2014
Ajinomoto Althea, Inc. Receives European GMP Certification 9/3/2014
U.S. FDA Grants QIDP Status For Wockhardt (WOCKHARDT.BO) Anti-Infective Drug Discovery Program 9/2/2014
Tianyin Pharmaceutical Co, Inc. Submits Dataset For GMP Inspection At Qionglai Facility (QLF) 8/29/2014
FDA Chastises Alexion Pharmaceuticals Inc. (ALXN) For Production Problems Again 8/28/2014
m2p-labs' Environmental Management System Successfully Certified 8/27/2014
Cesca Therapeutics Advocates Benefits Of Cell Therapy To The Centers for Medicare & Medicaid Services 8/27/2014
CEN Biotech Announces The Completion Of Its Pre-License Inspection By Health Canada 8/26/2014
Apotex Inc. Release: NAFTA Tribunal Decision Supports FDA And Its Actions 8/26/2014
SANAFOR™ Antimicrobial Technology For Plastics, From Janssen PMP, Receives U.S. EPA Registration 8/21/2014
Exco Intouch Achieves Quality Milestone With Iso9001:2008 Certification 8/21/2014
FDA Finds Falsified Data, Serious Mold, And Decaying Frogs At Amanta (Formerly Known As Marck Biosciences) 8/21/2014
WuXi PharmaTech Co., Ltd. Facility Passes FDA Inspection For Manufacture Of API 8/18/2014
CVS Caremark Corporation (CVS)'s Accordant Health Services Receives NCQA Disease Management Accreditation 8/18/2014
Tianyin Pharmaceutical Co, Inc. Release: Qionglai Facility (QLF) Schedules September For GMP Examination 8/18/2014
FDA Advisory Committee Recommends Approval Of Tiotropium Respimat® For The Maintenance Treatment Of COPD 8/15/2014
Brunswick Labs Certification Program 2014 Q2 Activity Report 8/14/2014
Popular Toothpaste Contains Cancer-Causing Ingredient 8/13/2014
Protein Sciences Corporation And Liomont Announce Licensing Of Proprietary Influenza Vaccines For The Mexico Market 8/12/2014
Easton Pharmaceuticals (OP: EAPH) Announces Medical Marijuana Site Facility Visit And Inspection 8/12/2014
ZAI Lab Of Shanghai In-Licenses Two Respiratory Drugs From Sanofi 8/12/2014
Androgen Study Group Urges Investigation Into Ethical Violations By JAMA Regarding Controversial Testosterone Study 8/11/2014
Advanced Cell Diagnostics, Inc. Receives ISO 13485:2003 Certification 8/11/2014
Cardiome Pharma Corp. (COM.TO) Submits BRINAVESS Dossier To French Authorities To Support Market Access 8/7/2014
MD Anderson Cancer Center Postdoc Faked Results Of Novartis AG (NVS) Brain Tumor Study 8/7/2014
FDA Will Regulate Thousands Of Cancer, Genetic, And Other Diagnostic 8/5/2014
Raptor Pharmaceutical Inc. (RPTP) Receives Orphan Drug Designation For Cysteamine Bitartrate In Huntington's Disease From The European Commission 8/4/2014
ibidi Awarded With Seal Of Quality 8/4/2014
ATS Labs Release: EPA Approves Protocols For Antimicrobial Fogging & Misting Application Claims 8/4/2014
IMPAX Laboratories, Inc. (IPXL)'s Hayward Facility Continues To Disappoint The FDA 8/4/2014
Rock Creek Pharmaceuticals Provides Update Of Its European Drug Development Regulatory Strategy And Selects Quotient Clinical For Its Early Development Programs 8/1/2014
FDA Concern Over Drug Production Process At India's Cadila 7/31/2014
Israel's Ministry Of Health Approves Pluristem Therapeutics (PSTI)'s Commercial-Scale 3D Cell Manufacturing Process Used At Its New Haifa Facility 7/31/2014
Successful FDA Inspection At Hovione's API Manufacturing Plant In Cork, Ireland 7/31/2014
IMPAX Laboratories, Inc. (IPXL) Parkinson's Drug Future Shaky As FDA Cites Factory Issues 7/30/2014
Ampio Pharmaceuticals, Inc. (AMPE) Announces The FDA Has Issued A Written Response And Accepted The Ampio Plan For Beginning Production Of Ampion™ In The New Facility 7/30/2014
FDA Performs Inspection Of IMPAX Laboratories, Inc. (IPXL)'s Taiwan Facility 7/29/2014
Parnell Pharmaceuticals Holdings Acquires License For Intellectual Property And Rights To Develop Compounds For Bone And Dermal Regeneration 7/25/2014
Do Drugmakers Use An FDA Safety Program To Thwart Generics? 7/24/2014
India's Ipca Laboratories Halts Shipments To U.S. From Local Plant After FDA Concerns 7/24/2014
Agenus (AGEN) Release: First Vaccine Candidate for Malaria is Accepted for EU Regulatory Review 7/24/2014
Access Pharmaceuticals (ACCP) Receives 510(K) FDA Marketing Clearance For ProctiGard™ 7/22/2014
Vivione Biosciences Receives AOAC Certification, Positions Brand For Fast Growth In Food Industry 7/22/2014
Unique Pharmaceuticals, Ltd. Announces A Voluntary Nationwide Recall Of All Sterile Compounded Preparations Within Their Expiry Period Due To A Lack Of Sterility Assurance 7/21/2014
AltheaDx Laboratory Receives Accreditation From College of American Pathologists 7/21/2014
Novartis AG (NVS) Plant To Fall Under GlaxoSmithKline (GSK) Control 7/18/2014
Seres Health Makes Push For First Drug, And IPO, Of Microbiome Era 7/17/2014
Zynex (ZYXI.OB) Achieves Compound Pharmacy License Approval In 36 States 7/17/2014
U.S. Officials Fire 11 Scientists On Biosafety Panel In Midst Of Anthrax Crisis 7/16/2014
Repros Therapeutics Inc. (RPRX) Release: FDA Confirms Sperm And Testosterone Endpoints As Key Parameters For Assessment Of Androxal® Versus Approved Topical Gel And Placebo 7/16/2014
Federal Trade Commission Urged To Probe Shire, Sanofi (France) (SAN.PA) & Icahn Med School Over A "Conspiracy" 7/16/2014
AntiOp Release: FDA Designates Opioid Overdose Treatment For Fast Track Development Program 7/15/2014
Roche (RHHBY)'s Avastin Wins Priority Review For Cervical Cancer 7/15/2014
Bial And moksha8 Announce Exclusive License For The Commercialization Of Eslicarbazepine Acetate (Zebinix® / Exalief®) In Brazil And Mexico 7/15/2014
Ariad Pharmaceuticals, Inc. (ARIA) Announces Continuation Of Iclusig Review Under The Article 20 Procedure In Europe 7/14/2014
Questcor Pharmaceuticals, Inc. (QCOR) Finally Fesses Up To Adverse Events Data For Acthar 7/14/2014
QRxPharma Ltd. (QRXPY) Provides Feedback On End-of-Review Meeting With The FDA On Moxduo® 7/11/2014
HbA1c-direct™ From Carolina Liquid Chemistries Receives NGSP Certification 7/9/2014
GlaxoSmithKline (GSK) Has 30 Days To Clean Up Plant 7/8/2014
Aesica Meets New Serialization Requirements With A QAD ERP Upgrade 7/8/2014
Protein Sciences Corporation Receives Approval From FDA For 2014/15 Formulation Of Flublok® Influenza Vaccine 7/8/2014
Teva Pharmaceutical Industries Limited (TEVA) Tries Out A New Tactic In Battle For Generic MS Drug 7/7/2014
Beximco Pharmaceuticals Becomes First Bangladeshi Company To Receive GMP Approval From Taiwan Food and Drug Administration (TFDA) 7/7/2014
Recordati S.p.A : Carbaglu® Receives Orphan Drug Designation In The U.S. For Organic Acidemias 7/3/2014
Advaxis, Inc. Announces Filing For USDA Product License 7/2/2014
Aratana Therapeutics (PETX) Files For USDA Product License Of AT-014 Canine Osteosarcoma Immunotherapy 7/2/2014
FDA Slaps GlaxoSmithKline (GSK) With Warning For Plant Quality Violations, Orders Company To Review Manufacturing Worldwide 6/26/2014
Provista Diagnostics Laboratory Receives Accreditation From College of American Pathologists 6/26/2014
European Medicines Agency Release: Outcome Report On First European Collaboration Between Regulators And HTA Organisations 6/25/2014
Burzynski Research Institute Announces Lifting Of The FDA Partial Clinical Hold - Phase 3 Clinical Study Agreed Upon 6/24/2014
Cellectis (ALCLS)’ UCART19 Receives Advanced-Therapy Medicinal Product Classification From European Medicines Agency 6/23/2014
Centene Corporation's Kansas Subsidiary Awarded Accreditation From NCQA 6/18/2014
GrowBLOX Sciences, Inc. Secures Special Use Permit For Its Cultivation And Conversion Facility 6/18/2014
Harrisvaccines Becomes First In The Nation To Receive United States Department Of Agriculture (USDA) Conditional License For PEDv Vaccine 6/17/2014
US FDA Advisory Committee Recommends No Cardiovascular Outcomes Trial For Peripherally-Acting Mu-Opioid Receptor Antagonist (Pamora) Class Including Movantik 6/13/2014
AstraZeneca PLC (AZN) Release: FDA Adcom Recommends No CV Trial For PAMORA Class 6/13/2014
TxCell Granted Certificate Of GMP Compliance From ANSM For Cell Therapy Manufacturing Facility 6/12/2014
Sirion Biotech Release: Adenovirus Vectors Meet Critical FDA Requirement Regarding Risk Of Contamination With Infectious Agents 6/12/2014
European Medicines Agency Agrees Policy On Publication Of Clinical Trial Data With More User-Friendly Amendments 6/12/2014
Catalyst Clinical Resourcing, LLC Certified As A Woman Business Enterprise 6/10/2014
EffRx Receives U.S. Orphan Drug Designation For EX404 For Treatment Of Pediatric Polycystic Ovary Syndrome 6/10/2014
Europeans, U.S. Disagree Over Safety Of Ranbaxy Laboratories (RANBAXY.BO) Facility 6/6/2014
National Organization for Rare Disorders Urges FDA To Consider Rare Disease Treatment Implications When Setting Biologics Naming Policy 6/4/2014
PCI Given The Green Light In Anvisa Audit 6/4/2014
Sirona Biochem Announces Wanbang Biopharmaceuticals's Launch Of Pre-Clinical Validation 6/3/2014
IHMML Receives Conditional Zoning Approval From The Corporation Of Delta 6/2/2014
FDA Cites Manufacturing Concerns At Wockhardt (WOCKHARDT.BO)'s U.S. Unit 5/28/2014
Eisai Company, Ltd. (ESALY.PK)'s R&D Subsidiary Kan Research Institute Commences Full-Scale Operation at New Facility 5/26/2014
RXi Pharmaceuticals (RXII) Granted U.S. Notice Of Allowance Covering Self-Delivering (Sd-Rxrna) Technology Platform 5/22/2014
TxCell Release: Col-Treg Granted Advanced Therapy Medicinal Product (ATMP) Classification By The European Medicines Agency 5/22/2014
FDA Slams Sun Pharmaceutical Industries Ltd (SUNPHARMA.NS) For Continued Violations At Plant 5/22/2014
WuXi PharmaTech Co., Ltd. Toxicology Facility In Suzhou Passes OECD GLP Inspection 5/21/2014
CoreRx Expands Clinical Trial Supplies Manufacturing And Packaging 5/20/2014
Nordic Nanovector: Betalutin™ Granted Orphan-Drug Designation In The USA 5/20/2014
Medac Pharma, Inc. Announces Successful FDA Inspection Of Its Exclusive Methotrexate Manufacturer 5/15/2014
WuXi PharmaTech Co., Ltd. Facilities For Late- And Commercial-Stage Analytical And Stability Testing And Clinical-Trial Materials Manufacturing Pass FDA Audit 4/30/2014
Flamel Technologies (FLML) Announces Receipt Of Complete Response Letter From FDA Citing Issues At The Facility Of The Supplier Of The Active Ingredient 4/29/2014
Anaheim Clinical Trials (ACT) Clears Another FDA Inspection 4/29/2014
Pluristem Therapeutics (PSTI)'s Manufacturing Facility Approved By European Auditors For Phase 3 Trials 4/28/2014
Plandai Biotechnology, Inc. (PLPL.OB) Petitions South Africa Department Of Health For License To Conduct Cannabis Research 4/28/2014
Tolero Pharmaceuticals Receives FDA Orphan Drug Designation For Alvocidib For The Treatment Of Acute Myeloid Leukemia 4/23/2014
Salix Pharmaceuticals, Ltd. (SLXP) And Progenics Pharmaceuticals, Inc. (PGNX) Announce The Acceptance Of Submission To Expand The Use Of RELISTOR In Chronic Non-Cancer Pain By European Medicines Agency 4/22/2014
Vivione Biosciences Receives Coveted Letter Of No Objection (LNO) Designation From U.S. Department Of Agriculture Food Safety & Inspection Services 4/22/2014
Coldstream Laboratories Inc. Completes Successful FDA Inspection 4/21/2014
Lonza Inc.'s Facility In Singapore Received Good Manufacturing Practice (GMP) Certification From The HSA 4/17/2014
High Tech Solution For Controlling The Dengue Mosquito Is Approved By CTNBio 4/11/2014
FDA Release: Avita Medical Grants An Investigational Device Exemption For Compassionate Use Of ReCell 4/10/2014
ECCRT, A SynteractHCR Company, Recognized As An Accredited Training Facility By TransCelerate BioPharma 4/8/2014
FDA Moving Slow To Add Drug Inspectors In China 4/8/2014
Nexcyon Achieves European Regulatory Decision 4/7/2014
ChemCon GmbH Successfully Passes Its Fourth FDA Inspection 4/3/2014
Clinovo Release: Hands-On Trainings To Convert Clinical Data To CDISC SDTM Standards With CDISC Express 4/1/2014
IntegenX Announces ISO 9001:2008 Certification 4/1/2014
Abaxis, Inc. (ABAX) Receives CLIA Waiver For Capillary Sampling For Cholesterol, HDL And Triglycerides 4/1/2014
FDA Staff Raises Questions About MannKind Corporation (MNKD) Diabetes Device 3/28/2014
AXIS Clinicals Announces Successful Completion Of 13th U.S. FDA Audit 3/27/2014
Claimspartner® Becomes Second CIS Service Based Offering To Attain SSAE 16 Compliance 3/20/2014
Aesica Successfully Completes The Validation Of Its High Capacity Manufacturing Facility At Queenborough, UK Site 3/14/2014
POLARIS Announces Illumina CSPro Certification For Sequencing 3/14/2014
Northwest Biotherapeutics (NWBO) Receives Authorization For New Cancer Therapy In Accordance With $4 Billion German Medical Act 3/12/2014
ISPE To Conduct Quality Metrics Pilot Program With FDA Participation 3/12/2014
Mettler-Toledo (MTD) Release: Shedding New Light On Compliance And Regulatory Challenges 3/7/2014
FDA Approves Pluristem Therapeutics (PSTI)'s Commercial Scale Cell Manufacturing Process 3/6/2014
Regulatory Affairs Professionals Society Release: 257 Earn Regulatory Affairs Certification in Autumn 2013 3/5/2014
Pharmaron LLC Earns CFDA GLP Certification For Toxicology Facility 3/4/2014
Basilea Pharmaceutica (BSLN.SW) Reports That Isavuconazole Receives Qualified Infectious Disease Product Designation From FDA For The Treatment Of Invasive Mucormycosis 2/27/2014
ChinaBio(R) LLC Release: China Implements 30-Day Review For "Simple" M&A Transactions 2/26/2014
BioNJ Targets Streamlined Therapeutic Development With Clinical Trials Master Service Agreement Template 2/25/2014
Neurosearch A/S (NEUR.CO) Announces The Danish Business Authority's Decision In The Accounting Control Matter 2/21/2014
SCYNEXIS, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From The FDA For Antifungal Agent SCY-078 For Oral Use 2/21/2014
Intertek Microbiology Laboratory Achieves Bio-Safety Level 2 2/21/2014
Pluristem Therapeutics (PSTI) Submits FDA Orphan Drug Application For Preeclampsia 2/20/2014
Guerbet (GBT) Receives FDA Approval For A New Manufacturing Plant For Lipiodol® (Ethiodized Oil) Injection 2/20/2014
Selvita Received A GMP Certificate 2/18/2014
Shire plc's Massachusetts Facility Wins FDA OK To Manufacture Gaucher Disease Drug 2/14/2014
Pfizer Inc. (PFE) Statement On Today’s Joint Meeting Of FDA Advisory Committees 2/12/2014