| FDA Reporter

By FDA Reporter Submission | Aug 8, 2019

Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.

KALA PHARMACEUTICALS: Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial

By Press release submission | Aug 9, 2019

Targeting Topline Data from STRIDE 3 by the End of 2019

PERFUZE: Receives Breakthrough Device Designation Status from U.S. Food and Drug Administration (FDA) for Millipede CIS (Clot Ingestion System)

By Press release submission | Aug 9, 2019

Perfuze is developing novel catheter-based technology for treating acute ischemic stroke

FDA policymaker to keynote hemp business summit

By Sarah Downey | Aug 9, 2019

Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.

EndBrainCancer Initiative urges support, offers amendments

By Keri Carbaugh | Aug 9, 2019

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.

Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation

By Keri Carbaugh | Aug 9, 2019

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

Patients

By Press release submission | Aug 10, 2019

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

By Press release submission | Aug 12, 2019

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

By Press release submission | Aug 12, 2019

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

By John Severance | Aug 13, 2019

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

By Chris Adams | Aug 13, 2019

As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.

FDA Update: electronic submissions statistics

By FDA Reporter Submission | Aug 14, 2019

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

By Press release submission | Aug 14, 2019

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

Patients

By Press release submission | Aug 15, 2019

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

By Press release submission | Aug 15, 2019

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

By Press release submission | Aug 15, 2019

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

By Keri Carbaugh | Aug 16, 2019

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