Saturday, August 24, 2019

Saturday, August 24, 2019

Latest News

EMPHYCORP INC.: FDA Submission for Rx New Non-Steroidal Nasal Spray for Pulmonary Fibrosis w/ No Known Side Effects

EmphyCorp Inc., 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.

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.

Despite Right to Try Act, ALS patients still desperately wait for fatal disease drug treatments

People afflicted with the deadly and crushing disease amyotrophic lateral sclerosis (ALS) are searching for some glimmer of hope in the shadow of promising drug treatments, however ALS patients do not currently have real access to these drugs, which are presently in trials.

NUEROVIVE PHARMACEUTICAL: NeuroVive's NeuroSTAT Project Receives FDA Fast Track Designation

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.

QTBREATHEALTH: Brings FDA-cleared Technology for Radiation- and Compression-Free Breast Imaging to Scottsdale

Latest QTbreasthealth center now open within Scottsdale's Vincere Cancer Center, defining a new generation of breast imaging for women

LIPOCINE INC.: Receives FDA Clearance for Clinical Testing its NASH Candidate, LPCN 1144, in Expanded Target Population

Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") to clinically investigate LPCN 1144 in an expanded target population of adult male non-alcoholic steatohepatitis ("NASH") patients.

NOVARTIS PHARMACEUTICALS CORPORATION: FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101)

FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from standard ten months

U.S. FOOD AND DRUG ADMINISTRATION: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.

BECTON DICKINSON AND COMPANY: BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease (PAD) in the superficial femoropopliteal artery (SFA

Physician praises FDA plans to further assist doctors obtain experimental cancer treatments

WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.

CORMATRIX CARDIOVASCULAR, INC. receives FDA 510(k) clearance to market the Cor™ PATCH epicardial patch for tissue support and repair in adult patients

CorMatrix® Cardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients.

Cook, Los Angeles, Miami-Dade counties most at risk of measles outbreak, study finds

Illinois’ Cook County is the U.S. jurisdiction most at risk of a measles outbreak this year, according to a study published this month in the British medical journal The Lancet Infectious Diseases.

OCTAPHARMA USA: FDA Approves New Octaplas™ Product Label

New Labeling Reports Results of Post-Marketing Study Demonstrating Safety, Efficacy and Tolerability in Pediatric Patients

Measles cases in U.S. hit 839 so far this year, CDC reports

The number of U.S. measles cases confirmed this year reached 839 as of May 10, the highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.

ALLIANCE FOR SAFE BIOLOGIC MEDICINES: Physicians, Patients Overwhelmingly Support FDA Distinct Biologic Naming Plan, Suffixes for New Products

US physicians and patient advocacy organizations expressed their overwhelming support for the FDA's suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.

FDA Reporter