CDC Urges Return to In-Person School With Precautions CDC Urges Return to In-Person School With Precautions
On Tuesday, several CDC officials called for schools to reopen for in-person instruction and said that it can be done safely as long as certain precautions are taken.WebMD Health News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 27, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Signals of Serious Risks (FAERS) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 27, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: January 26, 2021
Coronavirus (COVID-19) Update (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
FDA has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Informaci ón actualizada sobre la dosis intravenosa de 32 mg de ondansetrón (Zofran) y productos previamente mezclados de ondansetrón
[12-5-12] La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) notificó a los profesionales de la salud que ya no se comercializará la dosis intravenosa de 32 mg de Zofran (hidrocloruro de ondansetrón), un medicamento para prevenir las náuseas, debido al potencial de serios ri esgos para el corazón (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Activities Report of the Generic Drugs Program (FY 2020) – FDARA Title VIII Section 807 and 805
Activities Report of the Generic Drugs Program (FY 2020) – FDARA Title VIII Section 807 and 805 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

DDT COA #000005: Diary for Irritable Bowel Syndrome Symptoms – Constipation (DIBSS-C)
DDT COA #000005: Diary for Irritable Bowel Syndrome Symptoms – Constipation (DIBSS-C) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure
Guidance listing the research activities involving human subjects that may be reviewed by the Institutional Review Board through the expedited review procedure authorized in 21 CFR 56.110. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000
Administrative/Procedural FDA Guidance (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 26, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

More Than One Third of COVID-19 Infections Are Asymptomatic More Than One Third of COVID-19 Infections Are Asymptomatic
A systematic review of 61 SARS-CoV-2 studies estimates the prevalence of asymptomatic infections.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 26, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

Glydo (Lidocaine HCI Jelly USP, 2%) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 26, 2021 Category: Drugs & Pharmacology Source Type: news

Lupkynis (Voclosporin Capsules) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 26, 2021 Category: Drugs & Pharmacology Source Type: news

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to con (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

The Changing Brain Signature of HIV The Changing Brain Signature of HIV
Potent anti-HIV therapy has been accompanied by a shift in the profile of HIV-related brain abnormalities beyond the basal ganglia, frequently implicated in the pre-cART era, to limbic structures.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 25, 2021 Category: Drugs & Pharmacology Tags: Neurology & Neurosurgery News Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir acerca del riesgo de da ño neurológico potencialmente permanente por el uso de antibióticos con fluoroquinolona inyectados o de uso oral
El 15 de agosto, 2013, La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) requirió que se actualicen las etiquetas del medicamento y las Guías del Medicamento para todos los antibióticos con fluoroquinolona para que describan mejor el serio efecto secundario de neuropatía periférica. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA requiere cambios en la etiqueta para advertir sobre problemas neurol ógicos graves pero poco frecuentes, tras una inyección epidural de corticosteroides para aliviar el dolor
[4-23-2014] La Administraci ón de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en inglés) advierte que, en casos poco frecuentes, la inyección de corticosteroides en el espacio epidural de la columna puede resultar en graves eventos adversos, como la pérdida de la visión, derrame cerebral, parálisis y mue rte. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Global Generic Drug Affairs
FDA ’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
Final Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, updated December 2018 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

UPDATED TIME AND PUBLIC PARTICIPATION INFORMATION: February 9, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 02/09/2021 - 02/09/2021
February 9, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2016
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2017
When it comes to innovation in the development of new drugs and therapeutic biological products, FDA ’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

RPS responds to Fitness to Practice consultation strategy
We'vesubmitted ourresponse to the GPhC’s consultation on its future strategy for managing fitness to practise concerns about pharmacy professionals. The strategy aims to give patients and th (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 25, 2021 Category: Drugs & Pharmacology Source Type: news

Nubeqa (Darolutamide Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 25, 2021 Category: Drugs & Pharmacology Source Type: news

Gimoti (Metoclopramide Nasal Spray) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 25, 2021 Category: Drugs & Pharmacology Source Type: news

Missed Opportunities for the Diagnosis of CRC in IBD Patients Missed Opportunities for the Diagnosis of CRC in IBD Patients
This root-cause analysis demonstrated that up to 2/3 of patients with inflammatory bowel disease who were eligible for colonoscopic surveillance had a missed opportunity to diagnose colorectal cancer.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 25, 2021 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Interstitial Cystitis (IC) and Painful Bladder Syndrome (PBS)
Title: Interstitial Cystitis (IC) and Painful Bladder Syndrome (PBS)Category: Diseases and ConditionsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 1/23/2021 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - January 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis
VICTORIA, British Columbia& ROCKVILLE, Md.-- January 22, 2021 -- Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lupkynis (voclosporin) in combination with a background... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Coronavirus (COVID-19) Update: January 22, 2021
Coronavirus (COVID-19) Update (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

April - June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Signals of Serious Risks (FAERS) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

British PM Says New Variant May Carry Higher Risk of Death British PM Says New Variant May Carry Higher Risk of Death
British Prime Minister Boris Johnson said on Friday the new English variant of COVID-19 may be associated with a higher level of mortality although he said evidence showed that both vaccines being used in the country are effective against it.Reuters Health Information (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 22, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma
Hematology / Oncology News Burst (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided by stage (Initiation Stage, Consultation and Advice Stage, Review Stage and Qualified). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Getting it Right: Retention Samples for BA and BE Studies - 03/19/2021 - 03/19/2021
Getting it Right: Retention Samples for BA and BE Studies (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

New Policy Lead for RPS Scotland
We are excited to announce that Laura Wilson has been appointed as the new Policy and Practice Lead for RPS in Scotland, following the retirement of Aileen Bryson. Laura will lead policy development (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Zeposia (Ozanimod Capsules) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Nexlizet (Bempedoic acid and Ezetimibe Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Barhemsys (Amisulpride Injection, for Intravenous Use) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Rukobia (Fostemsavir Extended-release Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Dojolvi (Triheptanoin Oral Liquid) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Inqovi (Decitabine and Cedazuridine Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Uplizna (Inebilizumab-cdon Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Evrysdi (Risdiplam for Oral Solution) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Monjuvi (Tafasitamab-cxix Injection ) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Blenrep (Belantamab Mafodotin-blmf for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Fintepla (FenfluramineOral Solution) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

Tecartus (Brexucabtagene Autoleucel Suspension) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 22, 2021 Category: Drugs & Pharmacology Source Type: news

What We Know and Don't Know About Virus Variants and Vaccines What We Know and Don't Know About Virus Variants and Vaccines
Leaders in infectious disease medicine address concerns about SARS-CoV-2 variants emerging in the US and globally, and assess the evidence.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 22, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
TITUSVILLE, N.J., January 21, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holde...
Source: Johnson and Johnson - January 22, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

U.S. Food and Drug Administration Approves Opdivo (nivolumab) in Combination with Cabometyx (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma
PRINCETON, N.J.--(BUSINESS WIRE) January 22, 2021-- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 22, 2021 Category: Drugs & Pharmacology Source Type: news