EndBrainCancer Initiative urges support, offers amendments
New guidelines proposed by the Food and Drug Administration are receiving support by the EndBrainCancer Initiative (EBCI). The new guidelines focus on diversity in clinical trials.
Latest News
Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation
The U.S. Food and Drug Administration has granted breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) based on clinical data from the 2019 American Society of Clinical Oncology (ASCO) annual meeting.
NINEPOINT MEDICAL: Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System
NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE® Imaging System for use in the pancreas and bile duct.
SHIMADZU MEDICAL SYSTEMS: Receives FDA 510(k) for the FLUOROspeed X1 RF system
Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, is proud to announce that they have received FDA 510(k) clearance for the FLUOROspeed X1, patient side conventional RF table system.
CONCEPT MEDICAL INC.: Granted 2nd 'Breakthrough Device Designation' From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first 'Breakthrough Device Designation' received by Concept Medical Inc. was on 30th April 2019 for its MagicTouch SCB, for the treatment of Coronary Artery Disease (CAD) in patients with in-stent restenosis.
Republicans look to Fair Care Act of 2019 to improve health insurance system
Some in Congress are hoping the Republican sponsored Fair Care Act of 2019 will open the floodgates for Americans to buy health insurance.
Drug-patent reform seeks accessibility, less data
As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.
FDA Update: electronic submissions statistics
Electronic regulatory submissions sent to the U.S. Food and Drug Administration have increased year-by-year since the electronic system was launched in 2009, the FDA reports.
CONSOLIDATED CONTAINER COMPANY: Envision Plastics First to Be Granted NOL by the FDA to Create Food Packaging From Recycled OceanBound Plastic
Many companies and brands have made significant, public commitments regarding sustainability.
EMPHYCORP INC.: FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis w/ No Known Side Effects
EmphyCorp Inc. www.EmphyCorp.com, a Private Corporation, is proud to announce the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its Orphan Drug Designations for the treatment of Interstitial Lung Diseases (ILD), which includes Pulmonary Fibrosis and Cystic Fibrosis.
GENETECH: FDA Approves Genentech’s Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors
First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain
AESCULAP IMPLANT SYSTEMS, LLC: Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL® Artificial Disc Compared to Previous Generation Lumbar Discs
Aesculap Implant Systems, LLC, a leader in lumbar motion preservation technology, today announced the e-publication of the "Five-year results of a randomized controlled trial for lumbar artificial discs in single level degenerative disc disease" in Spine
Dynacure receives orphan drug designation for drug to treat Centronuclear Myopathies
DYN101, an investigational antisense medication for Centronuclear Myopathies (CNM), has received Orphan Drug Designation, according to the drug development company Dynacure.
Some flavored e-liquid and hookah tobacco products to be removed
Warning letters were issued by the U.S. Food and Drug Administration to four companies who do not have the required marketing authorization for 44 flavors of e-liquid and hookah tobacco products.
Jeff Berg Assumes Top Leadership Role at AbelsonTaylor With Appointment to President
Founder Dale Taylor Will Remain CEO and Chairman of the Board
ABBVIE: Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).1 RINVOQ is expected to be available in the U.S. in late August 2019.
NATIONAL KIDNEY FOUNDATION: IgA Nephropathy Patients Invited to Speak About their Disease to the FDA
National Kidney Foundation and IGAN Foundation of America organizing meeting to hear voices of patients with this chronic kidney disease
EDWARDS LIFE SCIENCES CORPORATION: Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients
Superior TAVR Valve Available for All Patients Diagnosed with Severe, Symptomatic Aortic Stenosis
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PROFOUND MEDICAL: Receives U.S. FDA 510(k) Clearance for TULSA-PRO®
U.S. Commercial Launch Expected in the 4th Quarter of 2019
ADAGIO MEDICAL: Announces US FDA Investigational Device Exemption Approval With Conditions To Conduct A Clinical Study For Treatment Of Persistent Atrial Fibrillation Using The Ultra-Low Temperature Cryoablation System
Adagio Medical, Inc. (Adagio), the developer of iCLAS™, the company's ultra-low temperature intelligent continuous lesion ablation system, announced that it has received an Investigational Device Exemption approval with conditions from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for persistent atrial fibrillation (AF).