×
About 434,096 results
Pelvic Organ Prolapse ACOG Practice Bulletin, Number 214
https://journals.lww.com/greenjournal/Abstract/2019/11000/Pelvic_Organ_Prolapse__ACOG_Practice_Bulletin,.44.aspx
Obstetrics & Gynecology;

Nov 29th, 2019 - Pelvic organ prolapse (POP) is a common, benign condition in women. For many women it can cause vaginal bulge and pressure, voiding dysfunction, defecatory dysfunction, and sexual dysfunction, which may adversely affect quality of life. Women in the United States have a 13% lifetime risk of undergoing surgery for POP (1). Although POP can occur in younger women, the peak incidence of POP sympto...

Update on the Management of Constipation
https://jamanetwork.com/journals/jama/article-abstract/2754106
JAMA Wald A

Nov 16th, 2019 - Chronic constipation is very common. The most recent estimate of clinician visits attributable to constipation were from 2001 to 2004 and reported more than 8 million clinician visits in the United States, with most occurring in adult primary care settings (33%) followed by pediatric (21%) and gastroenterologist (14%) offices.1 These encounters result in large expenditures for nonprescription l...

Depression in Children and Adolescents: Evaluation and Treatment
https://www.aafp.org/afp/2019/1115/p609.html
American Family Physician; Selph SS et al

Nov 16th, 2019 - he prevalence of major unipolar depression in children and adolescents is increasing in the United States. In 2016, approximately 5% of 12-year-olds and 17% of 17-year-olds reported experiencing a major depressive episode in the previous 12 months. Screening for depression in adolescents 12 years and older should be conducted annually using a validated instrument, such as the Patient Health Que...

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage
https://www.fda.gov/news-events/press-announcements/fda-approves-therapy-treat-patients-relapsed-and-refractory-mantle-cell-lymphoma-supported-clinical
FDA

Nov 16th, 2019 - The U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest...
https://www.ahajournals.org/doi/10.1161/CIR.0000000000000732
Circulation Panchal AR et al

Nov 16th, 2019 - The fundamentals of cardiac resuscitation include the immediate provision of high-quality cardiopulmonary resuscitation combined with rapid defibrillation (as appropriate). These mainstays of therapy set the groundwork for other possible interventions such as medications, advanced airways, extracorporeal cardiopulmonary resuscitation, and post–cardiac arrest care, including targeted temperature...

Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction
https://www.nejm.org/doi/full/10.1056/NEJMoa1912388?query=featured_home
New England Journal of Medicine; Tardif JC et al

Nov 16th, 2019 - Experimental and clinical evidence support the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis.

Snubbed by Scientists, Recognized 20 Years Later
https://www.medscape.com/viewarticle/920939
Medscape

Nov 16th, 2019 - When a team led by pathologist Robert Folberg, MD, noticed that uveal melanoma tumors seemed to organize themselves in packets, and between the packs were unexplained structures, the trajectory of their careers changed. The researchers found that some of the structures were solid and others were hollow, and the empty ones took the shape of channels containing red blood cells. At first, th...

FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance
https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-complicated-urinary-tract-infections-part-ongoing-efforts
FDA

Nov 16th, 2019 - The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.

Preexposure Prophylaxis for the Prevention of HIV Infection: Recommendation Statement
https://www.aafp.org/afp/2019/1115/od1.html
AAFP

Nov 16th, 2019 - Summary of Recommendation and Evidence The USPSTF recommends that clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition (Table 1). A recommendation.

2019 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; P...
https://www.ahajournals.org/doi/10.1161/CIR.0000000000000734
Circulation Soar J et al

Nov 16th, 2019 - The International Liaison Committee on Resuscitation has initiated a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation science. This is the third annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. It addresses the m...

FDA approves first contact lens indicated to slow the progression of nearsightedness in children
https://www.fda.gov/news-events/press-announcements/fda-approves-first-contact-lens-indicated-slow-progression-nearsightedness-children
FDA

Nov 16th, 2019 - The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.

Subclinical and Device-Detected Atrial Fibrillation: Pondering the Knowledge Gap: A Scientific Statement From the American Heart Association
https://www.ahajournals.org/doi/10.1161/CIR.0000000000000740
Circulation Peter A. Noseworthy, et al.

Nov 14th, 2019 - The widespread use of cardiac implantable electronic devices and wearable monitors has led to the detection of subclinical atrial fibrillation in a substantial proportion of patients. There is evidence that these asymptomatic arrhythmias are associated with increased risk of stroke. Thus, detection of subclinical atrial fibrillation may offer an opportunity to reduce stroke risk by initiating a...

Biggest Threats and Data 2019 AR Threats Report CDC’s Antibiotic Resistance Threats in the United States, 2019
https://www.cdc.gov/drugresistance/biggest-threats.html
CDC

Nov 14th, 2019 - CDC’s Antibiotic Resistance Threats in the United States, 2019 (2019 AR Threats Report) includes the latest national death and infection estimates that underscore the continued threat of antibiotic resistance in the U.S. According to the report, more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result. In addition, 223,900...

Diffuse large B cell lymphoma
https://www.cancertherapyadvisor.com/home/decision-support-in-medicine/hematology/diffuse-large-b-cell-lymphoma/
Cancer Therapy Advisor; Thomas M. Habermann

Nov 13th, 2019 - Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma that is potentially curable. DLBCL is the most common non-Hodgkin lymphoma (NHL) representing about 30% of all cases of NHL in the United States of America (USA) and Europe. There are over 76 different types of lymphoma. It is essential to establish the correct histological diagnosis prior to treatment.

NCCN Guidelines Insights: Kidney Cancer, Version 2.2020
https://jnccn.org/view/journals/jnccn/17/11/article-p1278.xml
JNCCN Motzer RJ, et al.

Nov 13th, 2019 - The NCCN Guidelines for Kidney Cancer provide multidisciplinary recommendations for the clinical management of patients with clear cell and non–clear cell renal cell carcinoma, and are intended to assist with clinical decision-making. These NCCN Guidelines Insights summarize the NCCN Kidney Cancer Panel discussions for the 2020 update to the guidelines regarding initial management and first-lin...

Marijuana Use Linked to Stroke, Arrhythmia in Young People
https://www.medscape.com/viewarticle/921116
Medscape

Nov 13th, 2019 - Use of marijuana is linked to a higher risk of stroke and hospitalization for cardiac arrhythmia in young people, two new studies suggest.

Diffuse Large B-Cell Lymphoma: ESMO Clinical Practice Guidelines
https://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma
Annals of Oncology; Tilly H et al

Nov 13th, 2019 - Diffuse large B-cell lymphoma is relatively common and represents 30%–58% of non-Hodgkin’s lymphomas. The updated ESMO Clinical Practice Guidelines provide information on the current management of diffuse large B-cell lymphoma including recommendations for screening and diagnosis, staging and risk assessment and stage-matched therapeutic strategies including specific recommendations for young a...

2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures
https://www.ahajournals.org/doi/10.1161/HCQ.0000000000000057
Circulation: Cardiovascular Quality and Outcomes; Casey E, et al.

Nov 12th, 2019 - In 2018, the Task Force convened the writing committee to begin the process of revising the existing performance measures set for hypertension that had been released in 2011.3 The writing committee also was charged with the task of developing new measures to evaluate the care of patients in accordance with the 2017 Hypertension Clinical Practice Guidelines.4 The writing committee developed a...

Evidence Mounts for Bariatric Benefit in Obesity-Related Cancer
https://www.medscape.com/viewarticle/921110
Medscape Busko, M

Nov 11th, 2019 - Two studies that provide further support for a potential benefit of a reduced risk of obesity-related cancers post-bariatric surgery were presented here at Obesity Week 2019.

Is There a Difference in Breast Cancer Recurrence Rates After Surgery With Regional vs General Anesthesia?
https://ascopost.com/news/november-2019/is-there-a-difference-in-breast-cancer-recurrence-rates-after-surgery-with-regional-vs-general-anesthesia/
ASCO Post; Stenger M

Nov 11th, 2019 - In a trial reported in The Lancet, Sessler et al found no difference in breast cancer recurrence after surgery with regional anesthesia-analgesia using paravertebral block and propofol vs general anesthesia with the volatile anesthetic sevoflurane and opioid analgesia. They also found no difference in persistent incisional pain between approaches.

Addition of Durvalumab to Etoposide Plus Platinum Chemotherapy for Extensive-Stage SCLC
https://ascopost.com/podcasts/addition-of-durvalumab-to-etoposide-plus-platinum-chemotherapy-for-extensive-stage-sclc/
ASCO Post;

Nov 10th, 2019 - This week, we’ll review an interim analysis of the CASPIAN trial, which evaluated the addition of durvalumab to etoposide plus platinum chemotherapy for extensive-stage small cell lung cancer. Then, we’ll talk about two recently issued guidelines on screening for colorectal cancer. Lastly, we’ll summarize some recent FDA approvals and announcements.

FDA approves first therapy to treat patients with rare blood disorder
https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treat-patients-rare-blood-disorder
FDA FDA

Nov 9th, 2019 - Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

Top 10 Medical Innovations for 2020, According to Cleveland Clinic
https://www.medscape.com/viewarticle/920936
Medscape

Nov 9th, 2019 - A dual-acting osteoporosis drug, minimally invasive mitral valve surgery, and a new treatment for peanut allergies are among the medical advances that will significantly transform the medical field and improve care for patients in the coming year, according to the Cleveland Clinic's list of top 10 medical innovations for 2020.

Commonly Abused Drugs Charts
https://www.drugabuse.gov/drugs-abuse/commonly-abused-drugs-charts
NIH

Nov 9th, 2019 - Many misused drugs can alter a person’s thinking and judgment, leading to health risks, including addiction, drugged driving and infectious disease. Most drugs could potentially harm an unborn baby; pregnancy-related issues are listed in the chart below for drugs where there is enough scientific evidence to connect the drug use to specific negative effects. Commonly Abused Drugs.

PRIMA Trial Reports Benefit With Niraparib Across Ovarian Cancer Subsets
https://ascopost.com/issues/november-10-2019/prima-trial-reports-benefit-with-niraparib-across-ovarian-cancer-subsets/
ASCO Post; Helwick C

Nov 9th, 2019 - In women with advanced ovarian cancer responding to first-line chemotherapy, maintenance therapy with the PARP inhibitor niraparib significantly reduced the risk of disease progression by 38% overall and by 60% in women with BRCA mutations. Even patients without a homologous recombination deficiency derived advantage from this treatment, in the phase III PRIMA/ENGOT-OV26/GOG-3012 trial presente...

Men With BRCA2 Should Be Screened for Prostate Cancer
https://www.medscape.com/viewarticle/921000
Medscape Davenport L

Nov 7th, 2019 - Men who carry the BRCA2 gene mutation, which is linked to breast and ovarian cancer, are at risk of developing aggressive prostate cancer and so should undergo regular prostate-specific antigen (PSA) testing, suggest findings from a major study.

Diffuse Large B-Cell Lymphoma
https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/
Lymphoma Research Foundation;

Nov 6th, 2019 - Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in the United States and worldwide, accounting for about 22 percent of newly diagnosed cases of B-cell NHL in the United States. More than 18,000 people are diagnosed with DLBCL each year.

BIOGEN AND ALKERMES ANNOUNCE FDA APPROVAL OF VUMERITY™ (DIROXIMEL FUMARATE) FOR MULTIPLE SCLEROSIS
http://investors.biogen.com/news-releases/news-release-details/biogen-and-alkermes-announce-fda-approval-vumeritytm-diroximel

Nov 5th, 2019 - Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) approved VUMERITY™ (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease...

FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older
http://www.news.sanofi.us/2019-11-04-FDA-approves-Fluzone-R-High-Dose-Quadrivalent-Influenza-Vaccine-for-adults-65-years-of-age-and-older

Nov 5th, 2019 - The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. Fluzone® High-Dose (Influenza Vaccine) was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadri...

Screening for Colorectal Cancer in Asymptomatic Average-Risk Adults: A Guidance Statement From the American College of Physicians
https://annals.org/aim/fullarticle/2754194/screening-colorectal-cancer-asymptomatic-average-risk-adults-guidance-statement-from
Annals of Internal Medicine;

Nov 5th, 2019 - The goal of this American College of Physicians (ACP) guidance statement is to guide clinicians on age to start and stop CRC screening, frequency of screening, and optimal screening test in asymptomatic, average-risk adults, based on a critical review of existing guidelines and their evidence reviews.

FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-next-generation-sequencing-test-detecting-hiv-1-drug-resistance

Nov 5th, 2019 - Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S.

Renin-Angiotensin System Inhibitors vs. Other Antihypertensive Drug Classes for Hypertension
https://www.aafp.org/afp/2019/1101/p540.html
American Family Physician; JEFFREY C. LEGGIT, MD

Nov 5th, 2019 - RAS inhibitors have been widely prescribed to treat hypertension; however, it remains unclear whether they are superior to other antihypertensive drugs in terms of clinically relevant outcomes for primary hypertension.

Millions of Americans have a substance use disorder. Help is available.
https://findtreatment.gov/
SAMHSA

Nov 5th, 2019 - The Substance Abuse and Mental Health Services Administration (SAMHSA) collects information on thousands of state-licensed providers who specialize in treating substance use disorders, addiction, and mental illness.

Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis
https://www.nejm.org/doi/full/10.1056/NEJMoa1909953
The New England Journal of Medicine; Tait, D. et. al.

Oct 28th, 2019 - BACKGROUND Results of an earlier analysis of a trial of the M72/AS01E candidate vaccine against Mycobacterium tuberculosis showed that in infected adults, the vaccine provided 54.0% protection against active pulmonary tuberculosis disease, without evident safety concerns. We now report the results of the 3-year final analysis of efficacy, safety, and immunogenicity. METHODS From August 201...

Scientists design device for oral delivery of injections
https://www.nih.gov/news-events/nih-research-matters/scientists-design-device-oral-delivery-injections

Oct 28th, 2019 - Biologic drugs are complex medications produced from living organisms or their parts. They include vaccines and drugs to treat conditions like rheumatoid arthritis, psoriasis, and cancer. Some biologic drugs, like insulin, can only be delivered by injection. If taken by mouth, stomach acid would destroy the drug before it could take effect.

Risk Factors and Cancer | CDC
https://www.cdc.gov/cancer/risk_factors.htm

Oct 28th, 2019 - Selected risk factors (things that increase your chance of getting cancer), including tobacco and alcohol use and human papillomavirus (HPV).

Shingles - Genetics Home Reference - NIH
https://ghr.nlm.nih.gov/condition/shingles

Oct 28th, 2019 - Shingles (also known as herpes zoster) results from infection by the varicella zoster virus. This common virus causes chickenpox (also known as varicella), which is characterized by itchy spots on the skin that cover the whole body and usually occurs in childhood or adolescence. After the body fights the initial infection, the varicella zoster virus remains in nerve cells for the rest of a per...

Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
https://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety

Oct 27th, 2019 - The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) when Endologix AFX endovascular grafts (AFX with Strata, AFX with Duraply, or AFX2) are used for the treatment of abdominal aortic aneurysms (AAA). We’ve previously communicated about the greater risk of Type III endoleaks occurring with the Endologix AFX with Strata device co...

Validation of the DNA Damage Immune Response Signature in Patients With Triple-Negative Breast Cancer From the SWOG 9313c Trial
https://ascopubs.org/doi/abs/10.1200/JCO.19.00693
Journal of Clinical Oncology; Sharma, P. et. al.

Oct 27th, 2019 - PURPOSE To independently validate two biomarkers, a 44-gene DNA damage immune response (DDIR) signature and stromal tumor-infiltrating lymphocytes (sTILs), as prognostic markers in patients with triple-negative breast cancer (TNBC) treated with adjuvant doxorubicin (A) and cyclophosphamide (C) in SWOG 9313. METHODS Four hundred twenty-five centrally determined patient cases with TNBC from ...

Pediatric Metabolic and Bariatric Surgery: Evidence, Barriers, and Best Practices
https://pediatrics.aappublications.org/content/early/2019/10/24/peds.2019-3223
Pediatrics Armstrong, S. et. al.

Oct 27th, 2019 - Severe obesity among youth is an “epidemic within an epidemic” and portends a shortened life expectancy for today’s children compared with those of their parents’ generation. Severe obesity has outpaced less severe forms of childhood obesity in prevalence, and it disproportionately affects adolescents. Emerging evidence has linked severe obesity to the development and progression of multiple co...

Efficacy and safety of anti-inflammatory agents for the treatment of major depressive disorder: a systematic review and meta-analysis of randomised controlled trials
https://jnnp.bmj.com/content/early/2019/08/29/jnnp-2019-320912
Journal of Neurology, Neurosurgery, & Psychiatry; Bai. S., et al

Oct 27th, 2019 - Objectives To systematically review the efficacy and safety of anti-inflammatory agents for patients with major depressive disorders. Methods We searched the literature to identify potentially relevant randomised controlled trials (RCTs) up to 1 January 2019. The primary outcome was efficacy, measured by mean changes in depression score from baseline to endpoint. Secondary outcomes included ...

Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis
https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(19)30401-8/fulltext
The Lancet Psychiatry; Black, N. et. al.

Oct 27th, 2019 - Medicinal cannabinoids, including medicinal cannabis and pharmaceutical cannabinoids and their synthetic derivatives, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), have been suggested to have a therapeutic role in certain mental disorders. We analysed the available evidence to ascertain the effectiveness and safety of all types of medicinal cannabinoids in treating symptoms of vario...

Breast Implants - Certain Labeling Recommendations to Improve Patient Communication
https://www.fda.gov/media/131885/download

Oct 23rd, 2019 - This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is issuing this draft guidance to help ensure that a patient receives and understands the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or under...

FDA Approves Botox® (Onabotulinumtoxina) For Pediatric Patients With Lower Limb Spasticity, Excluding Spasticity Caused By Cerebral Palsy
https://www.allergan.com/News/Details/2019/10/FDA%20Approves%20BOTOX%20onabotulinumtoxinA%20for%20Pediatric%20Patients%20with%20Lower%20Limb%20Spasticity%20Excluding%20Sp

Oct 23rd, 2019 - Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental Biologics License Application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP). This marks the 11th BOTOX® therapeutic indication, having been approved for pedi...

Breast Implants: Additional Resources
https://www.fda.gov/medical-devices/breast-implants/breast-implants-additional-resources

Oct 23rd, 2019 - This page suggests other resources for more information on breast implant issues

Melinta Therapeutics Announces U.S. FDA Approval of Supplemental New Drug Application for BAXDELA® (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
http://ir.melinta.com/news-releases/news-release-details/melinta-therapeutics-announces-us-fda-approval-supplemental-new

Oct 23rd, 2019 - Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (FDA) has approved BAXDELA® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible b...

Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32317-7/fulltext

Oct 23rd, 2019 - Uncertainty remains about the optimal monotherapy for hypertension, with current guidelines recommending any primary agent among the first-line drug classes thiazide or thiazide-like diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium channel blockers, and non-dihydropyridine calcium channel blockers, in the absence of comorbid indications...

Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer
https://www.nejm.org/doi/full/10.1056/NEJMoa1908075?query=featured_hematology-oncology
The New England Journal of Medicine; Kopetz, S. et. al.

Oct 23rd, 2019 - BACKGROUND Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy. Inhibition of BRAF alone has limited activity because of pathway reactivation through epidermal growth factor receptor signaling. METHODS In this open-label, phase 3 trial, we enrolled 665 patients with B...

FDA approves niraparib for HRD-positive advanced ovarian cancer
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-hrd-positive-advanced-ovarian-cancer

Oct 22nd, 2019 - On October 23, 2019,the Food and Drug Administration approved niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mu...

Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants
https://www.fda.gov/news-events/press-announcements/statement-agencys-continued-efforts-protect-womens-health-and-enhance-safety-information-available

Oct 22nd, 2019 - The U.S. Food and Drug Administration is taking another significant step in protecting women’s health by helping to ensure patients have complete information about the benefits and risks of breast implants. In a draft guidance issued today, we are providing proposed labeling recommendations to manufacturers of these devices to help ensure women receive and understand information regarding the b...