News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    

Biotech/Pharma - Regulatory
Here's What Top Pharma Execs Expect Under Donald Trump 12/2/2016
Pharma Execs Weigh In On Possible Changes Under Trump 12/2/2016
Merck & Co. (MRK) CEO Kenneth Frazier: There Are Ways To "Strengthen And Improve" Obamacare Coverage 12/2/2016
CDG Biotech Is Poised To Enter The Market For Diagnostic Assay Solutions In The Fight Against Allergies And Rare Diseases 12/2/2016
Eisai Company (ESALY.PK) Release: Halaven (Eribulin) Receives Registration In South Africa For Treatment Of Women With Advanced Breast Cancer 12/1/2016
Pharma Needs To Have A Sense Of Urgency 11/30/2016
Gutsy Anti-Vaccine Activists Spot An Ally In The Oval Office 11/30/2016
Why FDA Delay on Brodalumab is Actually Great News For Valeant (VRX) 11/30/2016
Congress Poised To Pass Sweeping Law Covering FDA And NIH 11/30/2016
Biological Industries Announces FDA Drug Master File Acceptance For Nutristem hPSC XF Medium 11/30/2016
New Vetter Data Processing Center Is Officially Certified 11/30/2016
Even If Donald Trump Changed The FDA Drug Approval Process, Patients Wouldn't Benefit 11/29/2016
Will Trump Make Biotech ETFs Great Again? 11/29/2016
Warren Slams Cures Bill As Handout To "Big Pharma" 11/29/2016
Trump Presidency Impact On Biotechnology 11/29/2016
Axim Biotech Files IP Application On Propietary Method To Extract High-Purity THC 11/29/2016
Audentes (BOLD) Announces Initiation Of Large-Scale cGMP Production At Its Gene Therapy Manufacturing Facility 11/29/2016
StemGenex Comments On FDA Docket To Support Stem Cell Therapy 11/29/2016
How Malpractice Reform Affects Medical Device Innovation 11/29/2016
CombiMatrix (CBMX)’s Pre-Implantation Genetic Screening By Next Generation Sequencing Granted Conditional Approval From New York State Department Of Health 11/29/2016
Anuva Manufacturing Services Awarded ISO-13485:2003 Certification 11/29/2016
Easton Pharmaceuticals (OP: EAPH) Announces Negotiations For The Filing Of A Medical Marijuana Application In Jamaica Toward Exporting Medicinal Marijuana Into Various Countries Including Canada, Mexico, And Brazil 11/28/2016
MMJ PhytoTech United Greeneries Receives Cannabis Seed Import Permit 11/28/2016
Neovasc (NVC) Receives Regulatory Approval To Initiate TIARA II CE Mark Study 11/28/2016
Adapt Pharma Welcomes FDA Consumer Update Regarding Opioids 11/23/2016
Successful AAALAC Accreditation For Envigo Facilities In Barcelona, Spain 11/23/2016
Smith & Nephew Inc. (SNN) Release: New WHO Guidelines Recommend The Use Of NPWT To Help Reduce The Risk Of Surgical Site Infection 11/22/2016
Do CRISPR And Biotech Advances Pose A National Security Threat? 11/21/2016
UK Biotechs Struggle To Cope With Brexit 11/21/2016
WHO Declares Zika Public Health Emergency Over, Though Threat Remains 11/21/2016
GlaxoSmithKline (GSK) Files Regulatory Submission In U.S. For Once-Daily Closed Triple Combination Therapy FF/UMEC/VI For Patients With COPD 11/21/2016
Newt Gingrich Could Be Medical Science's Unlikely Champion During Trump's Presidency 11/18/2016
FDA Confirms A 510(K) De Novo Path For EyeGate Pharma’s Device, The Ocular Bandage Gel, Following Pre-Submission Meeting 11/18/2016
Renexxion Achieves Positive FDA Guidance For Phase 3-Ready GI Drug Naronapride 11/17/2016
Why Trump Should Be Good Medicine For The Pharma Industry 11/16/2016
Boehringer Ingelheim Welcomes Central Role Of LAMA/LABA Therapy Within 2017 GOLD Strategy For COPD 11/16/2016
Pfizer Canada Release: National Advisory Committee On Immunization (NACI) Gives Prevnar 13 Grade A Recommendation 11/16/2016
Marrone Bio Innovations, Inc Receives California Approval For MAJESTENE Bionematicide 11/16/2016
Nutra Pharma Corp. (NPHC) Announces Infomercial Campaign For Pet Pain-Away 11/16/2016
10 Twitter Experts To Help You Navigate Trump’s Health And Science Policy 11/15/2016
OWC Pharmaceutical Research Corp. To Submit Psoriasis Topical Cream IRB Safety Protocol To The Israeli National IRB ("Helsinki") Committee 11/15/2016
President Elect Donald Trump And FDA 11/14/2016
FDA Completes Transfer Of Emergency Use Authorization For Reebov Ebola Antigen Rapid Test To Zalgen Labs 11/14/2016
Amnio Technology's PalinGen And ProMatrX Lines Assigned Q Codes For Product Reimbursement 11/14/2016
ASPiRA LABS' OVA1 Technology Receives "Level B" Recommendation In The Latest ACOG Clinical Management Guidelines For The Management Of Adnexal Masses 11/11/2016
Fearful Of A Trump Administration, Many In Research Call For A "Tutorial" For The President-Elect 11/10/2016
Do Links Count? FDA To Re-Examine Online Drug Ads 11/10/2016
President-Elect Trump Could Deprive Women Of Reproductive Rights — Here's How Some Women Are Responding 11/10/2016
Florida Keys Voters Split On Genetically Modified Mosquito Trial 11/9/2016
Galileo Life Sciences, Inc. Files Application With OTC Markets 11/9/2016
Augmenix Announces New Category 1 CPT Code From The American Medical Association For Periprostatic Implantation Of Biodegradable Material 11/9/2016
Secant Group Launches Regenerez Extruded Component 11/9/2016
R&D Tax Incentives Are Critical To Building Australia's Innovation Economy, So Let's Get It Right 11/8/2016
Californians Still Hate Trump, But Are More Uncertain About Drug Companies 11/7/2016
How The Pharma Industry Is Supporting Republicans 11/7/2016
NeoTract, Inc. Release: UK Government Names Urolift System To Be Fast Track Funded For The NHS As A Strategically Important Product To Improve UK Healthcare 11/7/2016
Dangerous Infusion Errors Top ECRI Institute's Annual Health Technology Hazards List 11/4/2016
Atox Bio Announces Independent Safety Monitoring Committee Recommendation To Continue Phase 3 Study Of AB103 In Necrotizing Soft Tissue Infections 11/3/2016
FDA Granted E-QURE Approval To Initiate Its US Clinical Trial 11/3/2016
What Do Clinton And Trump Think On Biotech Issues? 11/2/2016
Medicines And Healthcare Products Regulatory Agency ("MHRA") Designates VTS-270 As A Promising Innovative Medicine 11/2/2016
EAG Laboratories Expands Pollinator Testing Capabilities To Meet Agrochemical Industry's Need To Comply With Emerging Regulations 11/2/2016
Mettler-Toledo (MTD) Release: New Weighing Guide: Efficient Weighing Workflows In The Pharmaceutical Industry 10/31/2016
Despite Controversies, China Follows Same Bioethical Regulations As The West 10/28/2016
Imprimis (immy) Registers Its New Jersey Facility With The FDA As An Outsourcing Facility 10/28/2016
FDA Clears VITROS Automation Solutions From Ortho Clinical Diagnostics 10/28/2016
After "Female Viagra," Muscular Dystrophy Drug, Will FDA Stand Firmer Against Pressure To Approve? 10/27/2016
Helius Medical Technologies To Receive ISO 13485 Certificate 10/27/2016
Concordia (CXR.TO) Announces Communication With CMA 10/26/2016
In A Tight Race, One Of Pharma's Favorite Senators Gets A Little Help From His Friends 10/25/2016
Johnson & Johnson (JNJ) to Stop Using Live Animals in Sale Rep Training 10/25/2016
Harvard Experts Fret Over the Fallout From FDA’s OK for Sarepta (SRPT)’s Controversial DMD Drug 10/25/2016
CFDA Addresses "80% of China Trials Are Based On Fraudulent Data" Story 10/25/2016
Soligenix (SNGX) Receives EMA Designation As Small And Medium Enterprise 10/25/2016
FDA Reclassifies Johnson & Johnson (JNJ) Acclarent's Aera Eustachian Tube Balloon to a Class II Device 10/25/2016
Fujitsu Announces That Renowned MRI Testing Facility, MAGNETIC RESONANCE SAFETY TESTING SERVICES, Confirms That Fujitsu UHF RFID Linen Tags Are Proven Suitable For Use In MRI Systems 10/25/2016
Keep Politics Out Of Science? Fugghedaboutit 10/24/2016
Sanders Urges Californians To Approve Drug Price Ballot Measure 10/24/2016
Panther Biotechnology Announces Meeting With U.S. FDA 10/24/2016
Cepheid (CPHD) Announces Receipt Of Required Regulatory Clearances In Proposed Acquisition 10/24/2016
Orthofix International NV (OFIX) Announces North American Spine Society Coverage Policy Recommendations For Electrical Bone Growth Stimulators 10/24/2016
Teva (TEVA) Rallies Despite FDA Warning Letter 10/21/2016
Allergan (AGN) Release: FDA Advisory Committee Recommends Approval Of SER120 (Desmopressin Nasal Spray) 10/21/2016
Pharma Reps May Have To Carry Special License In Chicago To Promote Drugs 10/20/2016
FDA Panel Backs Allergan (AGN)'s Drug For Frequent Nightly Urination 10/20/2016
Lannett (LCI) Comments On FDA Proposal Regarding Methylphenidate Extended Release Tablets 10/19/2016
Why Egalet's FDA PDUFA Delay Is No Cause For Panic 10/18/2016
Newest WikiLeaks Dump of Clinton Emails Exposes Some Biopharma Chatter 10/18/2016
Gramercy Extremity Orthopedics Passes Electromagnetic Compatibility Testing 10/18/2016
Pfizer (PFE) Retractions Point To The Need For Better Research Oversight 10/17/2016
Swinging at Wild Pitches, BioMarin (BMRN) Considering Appealing DMD Drug Rejection 10/17/2016
Canadian Generic Pharmaceutical Association Release: New Report: Regulatory Convergence Key To Ensuring Ongoing Supply Of Generic Prescription Medicines In Canada 10/17/2016
Health Canada Release; Information Update - Premature Battery Depletion With Certain St. Jude Medical (STJ) Implantable Defibrillators 10/17/2016
Sarepta (SRPT) Lands a Valuable Priority Review Voucher on Exondys 51 OK 10/14/2016
Valeant (VRX) Patient Access And Pricing Committee Comments On Recent Pricing Action Decisions 10/14/2016
Certara Corporation Establishes Phoenix PK/PD Centers Of Excellence In China And Japan 10/13/2016
Avacen Medical Announces Support For New ClinicalTrials.gov Initiative 10/13/2016
Carestream Health Ultrasound Systems Receive Health Canada License 10/13/2016
Regenicin, Inc. Announces Scheduled Pre-IND Meeting With FDA For Its New Autologous Cultured Skin Substitute, NovaDerm 10/12/2016
FDA Signs CRADA With CluePoints To Explore A Data-Driven Approach To Quality Oversight In Clinical Trials 10/12/2016
Chinese Vendors Openly Offer One Of The Most Lethal Opioids For Worldwide Export 10/11/2016
Syros Pharma Announces Approval Of Investigational Device Exemption (IDE) For Blood Test To Identify Cancer Patients With Proprietary Biomarkers 10/11/2016
BioStable Science & Engineering Completes Direct De Novo Application To FDA For The HAART 300 Aortic Annuloplasty Device 10/11/2016
BioElectronics Corporation Comments On Its U.S. FDA's OTC Market Clearance Application 10/10/2016
MYnd Analytics California Centers Receive CMS Approval 10/10/2016
Centene Corporation's Kansas Subsidiary Awarded Commendable Accreditation Status From NCQA 10/7/2016
Biostage Provides Regulatory Update of Cellspan Esophageal Implant 10/7/2016
Trump And Clinton Are Ignoring Science And Engineering -- A Key Part Of America's Future 10/6/2016
T-Cyte Launches First USDA-Approved Treatment Aid For Canine Osteoarthritis 10/6/2016
Martin Shkreli A Creature Of FDA Regulation, Not Pharma Industry's Greed 10/5/2016
Could Drug Checking Have Prevented Prince's Overdose Death? 10/5/2016
Ascentage Pharma's Lab Passes China National Standards Test 10/5/2016
CFDA: 80% Of China's Drug Applications Rely On Faulty Data 10/5/2016
AstraZeneca Canada (AZN) Release: Canada Denies Public Access To Potentially Life-Prolonging Ovarian Cancer Treatment LYNPARZA (Olaparib) 10/5/2016
Interpace Diagnostics Announces New York State Approval Of ThyGenX For Indeterminate Thyroid Nodules 10/5/2016
Obama Extends Controversial Program For Rare Pediatric Drugs 10/4/2016
Health Canada Authorizes Use Of Naloxone Nasal Spray 10/4/2016
Anatara Lifesciences APVMA Submission Major Milestone Achieved 10/4/2016
Trinity Biotech (TRIB) Cuts Jobs in Shutdown of Swedish Facility, Withdraws Device App With the FDA 10/4/2016
BioDirection Files Pre-Submission Package With FDA 10/4/2016
Heart Test Labs Completes Regulatory Submission For Both FDA 510(K) And CE Mark 10/4/2016
EXACT Sciences (EXAS) Announces Inclusion Of Cologuard In HEDIS Quality Measures 10/4/2016
BioPharm Executive: Did the FDA Just Destroy Its Credibility? 10/3/2016
FDA Warns Against The Use Of Homeopathic Teething Tablets And Gels 10/3/2016
FDA Grants Valencia Technologies IDE Approval For U.S. Pivotal Study Of Bioelectronic Device For Hypertension 10/3/2016
Ampio Pharmaceuticals, Inc. (AMPE) Updates Clinical And Regulatory Activity 9/30/2016
Does The FDA Have A High Enough Standard For Drug Approvals? 9/29/2016
Biotechs Leverage Patient Groups In Drug Development 9/29/2016
FDA's Clinical Investigator Training Helps Support The Drug Development Process 9/29/2016
Serametrix Gains CLIA Certification For MDSC-Based Blood Test For Predicting Response To Immunotherapy In Cancer Patients 9/29/2016
It's a Big Problem When The FDA's Drug Reviewers Keep Leaving To Work For Big Pharma 9/28/2016
GW Pharma (GWPH) Gets Closer To Forcing FDA On Cannabis 9/28/2016
Pharma Start Announces Successful Transition Reassessment To The ISO 9001:2015 Standard 9/28/2016
Clinton, Trump Share Big-Pharma Attack Goals, Andrew Left Says 9/27/2016
Minority Inclusion in Clinical Trials: When Diversity Priorities Show 9/27/2016
N&N Pharma Release: N-Methanocarbathymidine Granted Orphan Drug Designation In The U.S. 9/27/2016
New Standards For Forensic Grade Manufacturing Integrated At Promega Corporation 9/27/2016
MDxHealth, Inc. (MXDHF) Announces Independence Blue Cross Rendered Positive Medical Coverage Policy For ConfirmMDx 9/27/2016
Merck & Co. (MRK)’s Keytruda Finds Fast Entry Into China Via Medical-Tourism Push 9/26/2016
Good Pharma Scorecard: Pharma's Worst Fear or Newest Ally? 9/26/2016
Regentis Biomaterials Receives IDE Approval For Pivotal GelrinC Clinical Trial 9/26/2016
35 U.S. States Sue British Drugmaker Indivior Over Marketing of Opioid 9/23/2016
Ireland Makes Its Case to Be New Home for the EMA Following Brexit 9/23/2016
GENFIT (ALGFT): Successful Identification Of ROR?t Inverse Agonists As Candidates For Regulatory Pre-IND Studies 9/23/2016
Marketpoint Recall Expands To U.S., UK-Based Recall Response Specialist Provides Multilingual Support For U.S. Businesses 9/22/2016
Levita Magnetics Snags Class II Status for Gallbladder Surgery Device 9/22/2016
How Big Pharma Pressures States To Pay For Pricey Pills 9/21/2016
AACC Advocates Against Expanded FDA Oversight Of Laboratory Developed Tests To Senate HELP Committee 9/21/2016
Parenteral Drug Association's PAC iAM Task Force Releases Work Plan To Reduce Manufacturing Change Barriers 9/20/2016
Enzo Biochem (ENZ) Announces New York State Health Department Approval Of New Easily Adaptable, Cost Effective Cardiac Assay 9/20/2016
Here's How Rare Diseases Are Becoming Too Common 9/19/2016
Big Pharma Spends Millions To Keep Prices High For California Agencies 9/19/2016
HHS Issues New Rules To Open Up Data From Clinical Trials 9/19/2016
FDA Takes Back Special Protocol Assessment for Active Biotech (BTPC)'s Laquinimod 9/19/2016
Kerecis Wound-Treatment Product With Omega3 Fish Skin Now Eligible For Medicare Reimbursement In 45 States 9/19/2016
BIO Statement On Biosimilar User Fee Act Goals Letter 9/19/2016
California Life Sciences Association Answers ICER’s Call For Improvements To Its Value Assessment Framework For Evaluating New Therapies 9/19/2016
Biotalent Canada To Assist Ontario Biotech Companies With Accessibility-Compliance Reporting 9/19/2016
Humana, Inc. (HUM) CEO: We Are Using Retail Consumer Behavior Analytics To Personalize Care 9/19/2016
Neogen Corporation (NEOG)'s AccuPoint Advanced Receives AOAC Approval 9/19/2016
Lannett (LCI) Announces Successful FDA Inspections Of Three Facilities 9/19/2016
Seattle Biotechs Still Hurting From Election Season "Witch Hunt" 9/16/2016
Acclarent: FDA Permits Marketing Of Balloon Device To Treat Persistent Eustachian Tube Dysfunction 9/16/2016
Government Hypocrisy Over EpiPen: The Pot Calling The Kettle Black 9/15/2016
Centene Corporation Expands Marketplace Offering In Arizona 9/15/2016
PCI Synthesis Obtains DEA Registration For Controlled Substance Development And Manufacturing 9/15/2016
Bone Therapeutics Receives Positive Ruling On Belgian Patent Income Deduction 9/15/2016
MiMedx Urges FDA To Reconsider Draft Guidances During Hearing 9/15/2016
The Candidates' Views On America's Top 20 Science, Engineering, Tech, Health & Environmental Issues In 2016 9/14/2016
What The DEA's Plan To Schedule 1 Kratom Will Mean For Millions 9/14/2016
Will FDA’s Scrutiny of Pfizer (PFE)’s Chantix Trial Go Up in Smoke? 9/13/2016
Sparta Systems, Inc. Partners With Navitas To Provide Comprehensive Solution For IDMP Compliance 9/13/2016
FDA Approves The Cleveland Cord Blood Center's CLEVECORD For Stem Cell Transplants 9/13/2016
Johnson & Johnson (JNJ) Announces WHO Will Review Ebola Vaccine Regimen For Emergency Use Assessment And Listing (EUAL) 9/13/2016
The Alliance for Regenerative Medicine (ARM) Submits Comments In Response To FDA Draft Guidances On The Regulation Of Human Cells, Tissues Or Cellular Or Tissue-Based Products 9/13/2016
FDA CONSUMER HEALTH INFORMATION: FDA Facilitates Research On Earlier Stages Of Alzheimer's Disease 9/13/2016
Organogenesis Release: Nation's Leading Developer Of Advanced Wound Care Technologies Urges FDA To Finalize Regulatory Guidance To Ensure Safety And Efficacy Of Section 361 HCT/Ps 9/13/2016
The Theranos Debacle: Why We Should Have Less Regulation Of Everything, Not More 9/12/2016
Akari Therapeutics Announces Receipt Of Orphan Drug Designation For Coversin From The FDA For Treatment Of Paroxysmal Nocturnal Hemoglobinuria 9/12/2016
Bavarian Nordic (BAVA.CO) Announces That Janssen Has Completed A Submission For Emergency Use Assessment And Listing For Its Ebola Vaccine Regimen To WHO 9/12/2016
Are Geneticists Who Work For Corporations Really Less Ethical Than University Researchers? 9/9/2016
European Chemicals Agency Supports Novartis AG (NVS) Over Use of Toxic Chemical in Drugs 9/9/2016
FDA Expands Emergency Use Authorization For Hologic (HOLX)'s Aptima Zika Virus Assay To Include Use With Urine Samples 9/9/2016
QIAGEN N.V. (QGEN) Welcomes U.S. Guidance For Latent TB Testing In Primary Care 9/9/2016
Cancer Cures Could Already Exist In Big Data 9/8/2016
Embracing Technology Produces Good Regulatory Practice in Pharmaceutical Lifecycle Maintenance 9/8/2016
Anatara Lifesciences Successful Completion of Target Safety Study 9/8/2016
Apple (AAPL) Raises Explicit Guidelines for Mobile Medical and Health App Developers 9/8/2016
FDA Grants Special Designation To TAXIS Pharma Experimental Antibiotic 9/7/2016
Alzheimer’s Research UK Release: Loss Of Research Funding Is Top Brexit Fear For Dementia Scientists 9/6/2016
Eppendorf Striving To Ensure All Labs Are Smart, Safe, And Stress-Free, With Eppendorf Advantage 9/6/2016
Thermo Fisher Scientific (TMO) Pledges To Verify Specificity Of Antibodies In Accordance With New Antibody Validation Recommendations 9/6/2016
Aerotel Medical Systems's HeartLine ECG Monitors Win Colombian INVIMA Certification 9/6/2016
iuvo Bioscience Announces ISO 17025 Accreditation 9/2/2016
Evonik Industries Birmingham Laboratories Receives Renewal Of GMP Certification 9/2/2016
Becton, Dickinson and Company (BDX) Release: Mayo Clinic Proceedings Publishes New Insulin Injection And Infusion Recommendations 9/1/2016
FDA Requires Strong Warnings For Opioid Analgesics, Prescription Opioid Cough Products, And Benzodiazepine Labeling Related To Serious Risks And Death From Combined Use 9/1/2016
Evonik Birmingham Laboratories Receives Renewal Of GMP Certification 8/31/2016
PBOA Statement On Reauthorization Of The Generic Drug User Fee Amendments 8/31/2016
Health Canada Moving Quickly To Control Chemicals Used To Make Fentanyl 8/31/2016



//-->