Nigeria: Coronavirus - Nigeria Faces Drug Insecurity, Says NAFDAC
[This Day] Abuja -The National Agency for Food and Drug Administration and Control (NAFDAC) has warned that the current outbreak of the deadly coronavirus, officially named COVID-19, in China, puts the country in grave danger of drug insecurity, as most of the country's medicines are imported. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - February 18, 2020 Category: African Health Source Type: news

FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process
February 14, 2020 -- The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 15, 2020 Category: General Medicine Source Type: news

FDA Requests Market Withdrawal of Belviq Due to Cancer Risk
FRIDAY, Feb. 14, 2020 -- A clinical trial of the weight-loss drug Belviq (lorcaserin) shows an association with an increased risk for cancer, and the U.S. Food and Drug Administration is requesting that its maker withdraw the drug from the U.S.... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 14, 2020 Category: Pharmaceuticals Source Type: news

FDA seeks help to prevent vaping-related lung injuries
The U.S. Food and Drug Administration (FDA) has issued a public call for more...Read more on AuntMinnie.comRelated Reading: Most lung vaping cases linked to informal sources of THC CDC confirms vitamin E acetate in vaping cases Vaping-related lung injury cases trending downward CT links vaping to ARDS in new case studies (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 14, 2020 Category: Radiology Source Type: news

Drugmaker Eisai to withdraw weight loss drug Belviq after trials find cancer link
Eisai Co. will withdraw its weight loss drug Belviq after the US Food and Drug Administration said clinical trials showed an increased incidence of cancer among users, the company said. (Source: CNN.com - Health)
Source: CNN.com - Health - February 14, 2020 Category: Consumer Health News Source Type: news

Data from Basket Studies Help Anatomic Pathologists Better Understand Effectiveness of Oncology Drugs
Pathologists can be paid for their role in identifying and recruiting patients for basket studies and reporting results of medical laboratory tests Anatomic pathologists who biopsy, report, and diagnosis cancer will benefit from a better understanding of basket studies and their application in developing cancer treatment therapies. Such studies can lead to more documentation of […] (Source: Dark Daily)
Source: Dark Daily - February 14, 2020 Category: Laboratory Medicine Authors: Jude Tags: Uncategorized anatomic pathology basket studies biomarker BRAF gene cancer clinical laboratory Dark Daily dark intelligence group Dark Report FDA food and drug administration genetic medicine genetic mutation larotrectinib ma Source Type: news

FDA Requests Market Withdrawal of Diet Drug Belviq Due to Cancer Risk
THURSDAY, Feb. 13, 2020 -- A clinical trial of the weight-loss drug Belviq (lorcaserin) shows an association with an increased risk of cancer, and the U.S. Food and Drug Administration is requesting that its maker withdraw the drug from the U.S.... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - February 13, 2020 Category: General Medicine Source Type: news

More than half of US opioid prescriptions for dental procedures exceeded 3-day supply recommendations from CDC 2016 guidelines
New largescale study in the American Journal of Preventive Medicine found overprescription of opioids by dentists common, particularly to patients at high risk for substance abuse, and that almost 1/3 of patients received more powerful drugs than neededElsevierIMAGE: In this cross-sectional analysis of 542,958 dental visits by adult patients, between 1 in 4 and 1 in 2 opioid prescriptions exceeded the recommended morphine equivalents and days'supply for...viewmore Credit: Michelle S. Woods Ann Arbor, February 4, 2020 - Dentists are among top prescribers of opioids in the US, however, whether their opioid prescrib...
Source: Dental Technology Blog - February 13, 2020 Category: Dentistry Source Type: news

322,000 Insulin Pumps Recalled After Injuries, 1 Death Reported
(CNN) — Medtronic has recalled some of its insulin pumps after injuries and one death were reported due to the device malfunctioning, according to a US Food and Drug Administration announcement on Wednesday. The FDA identified it as a Class I recall, the most serious type of recall. Insulin pumps are small devices that can deliver insulin and help diabetes patients reach desired blood glucose levels as part of their management of the disease. Medtronic has recalled certain MiniMed 600 Series insulin pumps for delivering incorrect insulin dosing due to a missing or broken retainer ring, which helps lock the insulin ca...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - February 13, 2020 Category: Consumer Health News Authors: Health – CBS Boston Tags: Consumer Health News Syndicated CBSN Boston CNN Diabetes Source Type: news

Research calls for graphic warning labels to be added to cigarette packages
(MediaSource) Experts at the Center for Tobacco Research and The Ohio State University Comprehensive Cancer Center are making a case for why the U.S. Food and Drug Administration's (FDA) proposed rule to add 13 new graphic warnings for cigarette packages and advertisements should be allowed to go into effect. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - February 13, 2020 Category: Cancer & Oncology Source Type: news

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb ’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma
PRINCETON, N.J.--(BUSINESS WIRE) February 13, 2020 --Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2020 Category: Drugs & Pharmacology Source Type: news

Alternative to Alimta Coming for Mesothelioma Patients
The U.S. Food and Drug Administration has granted final approval of Pemfexy, a new brand of the chemotherapy drug pemetrexed, to combat malignant mesothelioma and advanced stage non-small cell lung cancer. The approval will allow oncologists to offer an alternative to Alimta, which today is considered standard pemetrexed and manufactured by Eli Lilly and Company. The chemotherapy drug is designed to block DNA replication and cell division. However, Pemfexy will not be available until February 2022. The FDA approval is limited to pleural mesothelioma patients whose disease is unresectable. Pemfexy is produced by Eagle Pharm...
Source: Asbestos and Mesothelioma News - February 12, 2020 Category: Environmental Health Authors: Matt Mauney Source Type: news

Medtronic recalls certain MiniMed insulin pumps tied to 1 death
Medtronic has recalled some of its insulin pumps after injuries and one death were reported due to the device malfunctioning, according to a US Food and Drug Administration announcement on Wednesday. (Source: CNN.com - Health)
Source: CNN.com - Health - February 12, 2020 Category: Consumer Health News Source Type: news

Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
Novartis announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC)(1). (Source: World Pharma News)
Source: World Pharma News - February 12, 2020 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

FDA reinstates Raleigh Radiology's accreditation
The U.S. Food and Drug Administration (FDA) on February 11 announced that it...Read more on AuntMinnie.comRelated Reading: Raleigh Radiology faces lawsuit over mammo services Mammo services halted at NC facility FDA posts warning for Texas mammography center FDA reinstates NC mammography facility's accreditation FDA posts alert for NC mammography facility (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 12, 2020 Category: Radiology Source Type: news

What would it take to make FMT mainstream? Two publications consider the opportunities
(Cell Press) Fecal microbiota transplant treatment for most microbiome-associated diseases has not been rigorously studied in humans--and any such studies would be subject to regulation by the Food and Drug Administration. In a pair of forums publishing February 12 in the journal Cell Host& Microbe, clinicians and an FDA scientist detail some areas of FMT research that could facilitate the development of safe and effective FMT therapies for patients. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 12, 2020 Category: International Medicine & Public Health Source Type: news

This drug maker's kidney disease treatment scores $50M payday
FibroGen Inc. will receive $50 million from partner AstraZeneca after federal regulators accepted the San Francisco company's application to approve a drug for treating anemia in chronic kidney disease patients. Acceptance of FibroGen's new drug application for the drug, called roxadustat, by the Food and Drug Administration means AstraZeneca plc (NYSE: AZN) must pay $50 million to FibroGen, the company said in a Securities and Exchange Commission filing Tuesday. Roxadustat, an oral small-molecule… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 12, 2020 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

This drug maker's kidney disease treatment scores $50M payday
FibroGen Inc. will receive $50 million from partner AstraZeneca after federal regulators accepted the San Francisco company's application to approve a drug for treating anemia in chronic kidney disease patients. Acceptance of FibroGen's new drug application for the drug, called roxadustat, by the Food and Drug Administration means AstraZeneca plc (NYSE: AZN) must pay $50 million to FibroGen, the company said in a Securities and Exchange Commission filing Tuesday. Roxadustat, an oral small-molecule… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 12, 2020 Category: Biotechnology Authors: Ron Leuty Source Type: news

Trump budget plan could push tobacco oversight out of the FDA
The Trump administration wants to fundamentally change the way the US government regulates tobacco and e-cigarette products, and the plan to move regulatory authority out of the US Food and Drug Administration is being met with strong condemnation from the public health community. (Source: CNN.com - Health)
Source: CNN.com - Health - February 11, 2020 Category: Consumer Health News Source Type: news

FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE) February 10, 2020 --Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the“Company”) today announced that it has received final approval from the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 11, 2020 Category: Drugs & Pharmacology Source Type: news

Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma
RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy. “W...
Source: Johnson and Johnson - February 10, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Product Recalls, Including Removals and Corrections
This guidance is intended to assist those members of industry regulated by the Food and Drug Administration (FDA) in handling all aspects of a product recall, including all corrections and removals. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 10, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Caption Health gets FDA nod for echo AI software
The U.S. Food and Drug Administration (FDA) said it has cleared artificial...Read more on AuntMinnie.comRelated Reading: Bay Labs changes name, gets FDA designation Bay Labs touts AI research at ASE 2019 AI firm Bay Labs touts upcoming ACC 2019 studies Bay Labs, Edwards collaborate on AI for heart imaging Bay Labs: AI software less variable than doctors for EF (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 10, 2020 Category: Radiology Source Type: news

Trevena again asks FDA to approve its experimental opioid pain reliever
Trevena Inc. said Monday it has resubmitted its new drug application for IV oliceridine, an opioid pain relief medicine designed to have fewer side affects than traditional opioids, to the Food and Drug Administration. The FDA in late 2018 rejected the Chester County biopharmaceutical company's application for oliceridine, which has the proposed brand name Olinvo, as a treatment for moderate-to-severe pain for patients while they are in the hospital. Trevena (NASDAQ: TRVN) conducted additional… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 10, 2020 Category: Biotechnology Authors: John George Source Type: news

Trevena resubmits a new drug application for its experimental opioid
Trevena Inc. said Monday it has resubmitted its new drug application for IV oliceridine, an opioid pain relief medicine designed to have fewer side affects than traditional opioids, to the Food and Drug Administration. The FDA in late 2018 rejected the Chester County biopharmaceutical company's application for oliceridine, which has the proposed brand name Olinvo, as a treatment for moderate-to-severe pain for patients while they are in the hospital. Trevena (NASDAQ: TRVN) conducted additional… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - February 10, 2020 Category: Biotechnology Authors: John George Source Type: news

Doctors group petitions FDA to require ED drug labels recommend plant-based diet
(Physicians Committee for Responsible Medicine) Package labels for Viagra, Cialis, and other erectile dysfunction (ED) drugs should inform patients that ED is a sign of potentially fatal artery disease, according to a petition the Physicians Committee for Responsible Medicine filed with the Food and Drug Administration on Feb. 10, 2020. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 10, 2020 Category: International Medicine & Public Health Source Type: news

Cadila Healthcare gets EIR from USFDA for its Ahmedabad facility
The company's topical manufacturing facility at Ahmedabad has received an EIR from the United States Food and Drug Administration (USFDA) signifying the successful closure of the audit, Cadila Healthcare said in a filing to the BSE. The facility completed the USFDA audit from December 16 to 20, 2019 with zero 483 observations, it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 10, 2020 Category: Pharmaceuticals Source Type: news

Deadly devices: Patients killed during surgery by heart device that RUPTURES, according to FDA report
(Natural News) The Food and Drug Administration (FDA) has issued an emergency Class I recall for a heart surgery device that has killed three people and injured another twenty-two. The device is made by one of the most trusted medical device manufacturers in the world and it has been used by some of the most... (Source: NaturalNews.com)
Source: NaturalNews.com - February 9, 2020 Category: Consumer Health News Source Type: news

FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User
Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user capture images of a patient's heart that are of acceptable diagnostic quality. (Source: eHealth News EU)
Source: eHealth News EU - February 7, 2020 Category: Information Technology Tags: Featured Industry Business and Industry Source Type: news

Test for Novel Coronavirus Approved for Wide Deployment
The US Food and Drug Administration authorizes the distribution of the 2019-nCoV diagnostic to state health departments and other facilities. (Source: The Scientist)
Source: The Scientist - February 6, 2020 Category: Science Tags: News & Opinion Source Type: news

UCLA research could be step toward lab-grown eggs and sperm to treat infertility
A new study on how and when the precursors to eggs and sperm are formed during development could help pave the way for generating egg and sperm cells in the lab to treat infertility.The study, published in the journal Cell Reports, describes the way in which human stem cells evolve into germ cells, the precursors for egg and sperm cells.“Right now, if your body doesn’t make germ cells then there’s no option for having a child that’s biologically related to you,” said Amander Clark, the study’s lead author, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem...
Source: UCLA Newsroom: Health Sciences - February 6, 2020 Category: Universities & Medical Training Source Type: news

Philadelphia consortium awards $200,000 to developers of pediatric medical devices
The Philadelphia-based Pennsylvania Pediatric Medical Device Consortium awarded $200,000 in seed grants this week to four startup companies in its latest round of funding to support promising projects addressing the health needs of children. The four companies to receive $50,000 each are developing devices for children with heartbeat arrhythmias, congenital heart disease, cerebral palsy, and developmental dysplasia of the hip. The consortium is funded by the Food and Drug Administration and based… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 6, 2020 Category: Pharmaceuticals Authors: John George Source Type: news

Public Notification: RMFLEX contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use RMFLEX, a product promoted and sold for joint pain and arthritis on various websites, including ebay.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: OrgaZEN Gold 5800 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use OrgaZEN Gold 5800, a product promoted and sold for sexual enhancement on various websites, including Amazon.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Alpha-Male contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Alpha- Male, a product promoted and sold for sexual enhancement on various websites, including Amazon.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: XXX Platinum WOODIE contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use XXX Platinum WOODIE, a product promoted and sold for sexual enhancement on various websites, including Amazon.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 6, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - 04/03/2020 - 04/03/2020
The Food and Drug Administration (FDA) is announcing a regional public meeting entitled ‘‘Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH)’’. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 5, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Moves Closer to Standardized Testing for Asbestos in Talc
The U.S. Food and Drug Administration moved closer on Tuesday to formulating standardized testing of talc-based products for the presence of toxic asbestos fibers. Experts from eight different federal agencies explained earlier recommendations at a day-long hearing. The session also featured input from 25 members of the public, which included industry representatives, consumer advocates and testing experts. “Standards are needed,” said Dr. Paul Howard, FDA Office of Regulatory Science, during his presentation. “They just don’t exist at this time.” Dr. Linda Katz, director of the FDA Office of ...
Source: Asbestos and Mesothelioma News - February 5, 2020 Category: Environmental Health Authors: Matt Mauney Source Type: news

FDA: Agency Information Collection Activities; Proposed Collection; Comment Request; Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations
The Food and Drug Administration is requesting comment on a research project entitled "Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADFs)," which will examine providers' perceptions, understanding, and behaviors related to opioid analgesic ADFs, as well as explore the effectiveness of terminology and descriptions for these products. Comments are due by April 6, 2020. (Source: Federal Register updates via the Rural Assistance Center)
Source: Federal Register updates via the Rural Assistance Center - February 5, 2020 Category: Rural Health Source Type: news

U.S. FDA expands use of CDC coronavirus diagnostic test
The U.S. Food and Drug Administration on Tuesday extended the use of a coronavirus detection tool to Centers for Disease Control and Prevention (CDC)-qualified laboratories across the country. (Source: Reuters: Health)
Source: Reuters: Health - February 4, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

U.S. government experts, industry spar over asbestos testing in talc
For the first time in nearly 50 years, the U.S. Food and Drug Administration examined asbestos testing for talc powders and cosmetics at a hearing on Tuesday, after traces of the known carcinogen were found in several such products, including Johnson& Johnson's Baby Powder. (Source: Reuters: Health)
Source: Reuters: Health - February 4, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

Past Outbreaks Provide a Roadmap for U.S. Government Response to Coronavirus Threat
While the threat of the new coronavirus in the United States remains limited, a network of U.S. government agencies are already furiously ramping up efforts to contain the disease, should an outbreak occur. “We are working to keep the risk low,” said Health and Human Services Secretary Alex Azar, who is leading the federal government’s response, at a press conference Friday. So far, the overwhelming number of new cases of the virus, which originated in Wuhan, China, remain in China. There are only 11 confirmed cases in the U.S. The good news, some officials and infectious disease experts tell TIME, is t...
Source: TIME: Health - February 4, 2020 Category: Consumer Health News Authors: Abigail Abrams Tags: Uncategorized Source Type: news

' Antibacterial' Soap Labels Still List Banned Ingredients'Antibacterial' Soap Labels Still List Banned Ingredients
In 2017, the US Food and Drug Administration banned several ingredients used in antibacterial soaps, but the compounds still appear in online listings.Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - February 4, 2020 Category: Allergy & Immunology Tags: Family Medicine/Primary Care News Source Type: news

Abbott's In-Development Fully Implantable Heart Pump System Earns FDA's Breakthrough Device Designation
ABBOTT PARK, Ill., Feb. 4, 2020 -- (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT) today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Imp... Devices, Cardiology, FDA Abbott, Left Ventricular Assist, heart failure (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 4, 2020 Category: Pharmaceuticals Source Type: news

FDA to hold public meeting on testing for asbestos in talc
For the first time in nearly 50 years, the U.S. Food and Drug Administration will examine asbestos testing for talc powders and cosmetics at a hearing on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - February 4, 2020 Category: Consumer Health News Tags: healthNews Source Type: news

Fact Sheet for Healthcare Providers: CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel
Source: U.S. Food and Drug Administration (FDA). Published: 2/4/2020. This three-page document informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Centers for Disease Control and Prevention (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This test is to be performed only using respiratory specimens collected from individuals who meet CDC criteria for 2019-nCoV testing. (PDF) (Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - February 4, 2020 Category: International Medicine & Public Health Source Type: news

Important Information for Blood Establishments Regarding the Novel Coronavirus Outbreak
Source: U.S. Food and Drug Administration (FDA). Published: 2/4/2020. The potential for transmission of novel coronavirus (2019-nCoV) by blood and blood components is unknown at this time. This web page provides information for blood establishments from the Food and Drug Administration (FDA), which is aware that some blood establishments are considering donor education and/or donor deferral measures in response to 2019-nCoV. As a precaution, blood establishments may wish to consider whether to provide donor education, encourage self-deferral, and manage post-donation information about 2019-nCoV. (Text) (Source: Disaster L...
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - February 4, 2020 Category: International Medicine & Public Health Source Type: news

FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine
HOLLY SPRINGS, N.C., Feb. 3, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved Audenz™ (Influenza A (H5N1) Monovalent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2020 Category: Drugs & Pharmacology Source Type: news

United Therapeutics gets disappointing news on cancer therapy
United Therapeutics Corp. ’s (NASDAQ: UTHR) trial of one of its cancer therapies in small cell lung cancer did not achieve its goals, the company announced Monday. The Silver Spring company conducted a trial, called a DISTINCT study, of Unituxin in patients with some forms of small cell lung cancer, but said Monday that the therapy did not extend the overall survival of those patients.  Unituxin, or dinutuximab, first received approval from the Food and Drug Administration in March 2015 to treat… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 3, 2020 Category: Pharmaceuticals Authors: Rebecca Cooper Source Type: news

7D Surgical Expands Spine and Cranial Technology Offering
TORONTO, Feb. 3, 2020 -- (Healthcare Sales & Marketing Network) -- 7D Surgical announced today important additions to its cranial and spinal product lines. The company has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) an... Devices, Neurosurgery, FDA, Product Launch 7D Surgical, Cranial Biopsy, MvIGS (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 3, 2020 Category: Pharmaceuticals Source Type: news