Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy
South San Francisco, CA -- November 21, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Venclexta (venetoclax), in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Daiichi Sankyo ’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Tokyo, Munich and Basking Ridge, NJ– (November 21, 2018)– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 21, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis
November 20, 2018 -- The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

Risk Factors for Postoperative Recurrence in Crohn's Disease Risk Factors for Postoperative Recurrence in Crohn's Disease
This study aimed to identify predictors of postoperative endoscopic recurrence in Crohn's disease patients who have undergone ileocolonic resection.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 20, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 20, 2018-- Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 20, 2018 Category: Drugs & Pharmacology Source Type: news

Onset of Musculoskeletal Adverse Events Varies Between Statins
MONDAY, Nov. 19, 2018 -- The onset of musculoskeletal adverse events (MAEs) during statin monotherapy is significantly faster with use of atorvastatin and rosuvastatin versus simvastatin, according to a study published online Nov. 7 in Pharmacology... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 19, 2018 Category: Pharmaceuticals Source Type: news

Tikosyn (Dofetilide) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 19, 2018 Category: Drugs & Pharmacology Source Type: news

Betapace AF (Sotalol Hcl) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 19, 2018 Category: Drugs & Pharmacology Source Type: news

Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name
IRVINE, Calif., Nov. 19, 2018 (GLOBE NEWSWIRE) -- Evolus, Inc. (NASDAQ: EOLS), a company dedicated to aesthetic medicine, today announced the conditional acceptance from the U.S. Food and Drug Administration (“FDA”) of the Jeuveau™... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 19, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Aemcolo (rifamycin) to Treat Travelers ’ Diarrhea
November 16, 2018 -- The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 16, 2018-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced a new approval for Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

Citanest Forte Dental (Prilocaine HCl and Epinephrine Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

Citanest Plain Dental (Prilocaine hydrochloride Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

Emgality (galcanezumab-gnlm)
Title: Emgality (galcanezumab-gnlm)Category: MedicationsCreated: 11/16/2018 12:00:00 AMLast Editorial Review: 11/16/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Promacta (eltrombopag) for First-Line Severe Aplastic Anemia
Basel, November 16, 2018 - Novartis announced today that the US Food and Drug Administration (FDA) has expanded the label for Promacta (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with severe... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2018 Category: Drugs & Pharmacology Source Type: news

MHRA Drug Safety Update: Hydrochlorothiazide: risk of non-melanoma skin cancer particularly in long-term use
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update: Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use... (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Medical device alert: All T34 ambulatory syringe pumps – update concerning battery information
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a updatefor all T34 ambulatory syringe pumps manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company. An addition (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Seromycin (Cycloserine Capsules ) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Sympazan (Cobazam Oral Film) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Yupelri (Revefenacin Inhalation Solution) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Complera (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Liver Fat Scores Predict Liver Disease Mortality in the US Liver Fat Scores Predict Liver Disease Mortality in the US
This study examined how markers of liver health are associated with mortality in persons without viral hepatitis in the United States. Are liver fat scores useful for metabolic health surveillance?Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 15, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018
MAHWAH, N.J., Nov. 15, 2018 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the company is presenting new data for for its leading respiratory pipeline candidate Ryaltris (rye - al' - tris)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 15, 2018 Category: Drugs & Pharmacology Source Type: news

Medical device alert: Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags – potential breach in sterile barrier packaging
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medical device alert for specific lots of Suction Catheters,GastroenteralTubes, Intermittent Urology Catheters and sterile U (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Dsuvia (Sufentanil Sublingual Tablet) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Lorbrena (Lorlatinib Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Udenyca (Pegfilgrastim-cbqv Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Alunbrig (Brigatinib Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 14, 2018 Category: Drugs & Pharmacology Source Type: news

Ranexa (Ranolazine) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 13, 2018 Category: Drugs & Pharmacology Source Type: news

Drug-induced Liver Injury in the Context of NAFLD Drug-induced Liver Injury in the Context of NAFLD
This article explores the pathophysiological mechanisms and reciprocity involved in NAFLD and drug-induced steatohepatitis.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 13, 2018 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Merck Begins Rolling Submission of Licensure Application for V920 (rVSV ∆G-ZEBOV-GP) to U.S. Food and Drug Administration
KENILWORTH, N.J.--(BUSINESS WIRE) November 13, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it has started the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 13, 2018 Category: Drugs & Pharmacology Source Type: news

Company led recall: Mitomycin-C Kyowa 10mg Powder for Solution for Injection
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company led recall for a specific batch of Mitomycin-C Kyowa 10mg Powder for Solution for Injection PL 16508/0043, because a (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 12, 2018 Category: Drugs & Pharmacology Source Type: news

Antibiotic resistance is still a global threat
Today is World Antibiotic Awareness Week, which aims to increase awareness of global antibiotic resistance and to spread wider public understanding of the issue. Our spokesperson Neal Patel was inter (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 12, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
November 09, 2018 -- Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

RPS meets Dept of Health on Brexit contingency plans
The Royal Pharmaceutical Society on Thursday met with the Department of Health and Social Care to discuss potential implications of Brexit for patients, pharmacists and the wider NHS. President Ash S (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

Steglatro (Ertugliflozin Tablets for Oral Use) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

Steglujan (Ertugliflozin and Sitagliptin Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

Qmiiz-ODT (Meloxicam Orally Disintegrating Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

Xodol (Hydrocodone Bitartrate and Acetaminophen Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib
KENILWORTH, N.J.--(BUSINESS WIRE) November 9, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2018 Category: Drugs & Pharmacology Source Type: news

RPS talks to BBC Radio Scotland about danger of buying diet pills online
RPS spokesperson and Deputy Director for Scotland, Aileen Bryson, has been interviewed this morning by BBC Radio Scotland about the access to diet pills online. Aileen was invited to share her views (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 8, 2018 Category: Drugs & Pharmacology Source Type: news