FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myeloma
Listen to a soundcast of the March 26, 2021 FDA approval of ABECMA (idacabtagene vicleucel) the first cell-based gene therapy for treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remarks by Dr. Janet Woodcock to the 2021 Rx Drug Abuse and Heroin Summit - 04/08/2021
Remarks by Dr. Janet Woodcock, Acting Commissioner of Food and Drugs, 2021 Rx Drug Abuse and Heroin Summit, April 8, 2021 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies
Listen to a soundcast of the March 10, 2021 FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test
Listen to a soundcast of the March 3, 2021 approval of Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapy
Listen to a soundcast of the February 26, 2021 FDA approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adults patients with refractory multiple myeloma who received at least four prior lines of therapy. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations
Listen to a soundcast of the February 22nd 2021 FDA approval of Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lateral flow COVID-19 tests now available from pharmacies in England
RPS England Board member Ash Soni was interviewed by BBC Breakfast, following the launch of the NHS community pharmacy COVID-19 lateral flow device distribution service in England. Otherwise known as (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - April 9, 2021 Category: Drugs & Pharmacology Source Type: news

Why Employee COVID Vaccination Mandates May Not Be Legal Why Employee COVID Vaccination Mandates May Not Be Legal
Until vaccines get full FDA approval, it's not clear that employers -- including healthcare systems -- can legally require workers to get shots, a Kaiser Family Foundation report says.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 9, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

US Finally Hits Its Stride With COVID-19 Vaccination Rollouts US Finally Hits Its Stride With COVID-19 Vaccination Rollouts
Nation hits new record with 4.1 million people vaccinated in single day. But far fewer Blacks, Hispanics have gotten vaccine doses.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 8, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el coraz ón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitinib)
Los resultados iniciales de un ensayo de seguridad revela un mayor riesgo de padecer problemas graves relacionados con el coraz ón y cáncer con los medicamentos para la artritis y la colitis ulcerosa Xeljanz y Xeljanz de liberación prolongada (tofacitinib) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
. FDA now requiring studies to evaluate heart risk across the drug class (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

HEALTH CARE HEROES: Kenneth Palmer
Kenneth Palmer is director of the Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases at the University of Louisville and professor of pharmacology and toxicology in the University of Louisville School of Medicine. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 8, 2021 Category: Biotechnology Source Type: news

Applications to join new RPS Expert Advisory Groups now open
We are recruitingmembers for three new Expert Advisory Groups, which are being set up to provide a fresh source of expertise on issues relating to the pharmacy profession. The groups will work on iss (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - April 8, 2021 Category: Drugs & Pharmacology Source Type: news

About Mineral - 613984 - 04/07/2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

October - December 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 - April 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Allure Imports - 613211 - 04/07/2021
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Technescan MAG3 (Technescan tc 99m Mertiatide for Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 8, 2021 Category: Drugs & Pharmacology Source Type: news

Technescan HDP (Kit for the Preparation of Technetium Tc 99m Oxidronate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 8, 2021 Category: Drugs & Pharmacology Source Type: news

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer
FDA granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil
Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000,& Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) in (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves new dosing regimen for cetuximab
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 - April 7, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

RPS President Sandra Gidley not seeking re-election
RPS President Sandra Gidley will not be seeking re-election to the English Pharmacy Board this year. Sandra was Chair of the English Pharmacy Board from June 2015-2019 and has been RPS President since (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

Non-invasive Prognostic Tests for Primary Sclerosing Cholangitis Non-invasive Prognostic Tests for Primary Sclerosing Cholangitis
This paper reviews a wide variety of prognostic models for primary sclerosing cholangitis, including serum biomarkers, elastography scores, and MRI scores.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 7, 2021 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news

Kapspargo Sprinkle (Metoprolol Succinate Capsules ) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

Goprelto (Cocaine Hydrochloride Nasal Solution) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

Bridion (sugammadex)
Title: Bridion (sugammadex)Category: MedicationsCreated: 4/7/2021 12:00:00 AMLast Editorial Review: 4/7/2021 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

Men and Women Differ on Masks During, After COVID-19: Survey Men and Women Differ on Masks During, After COVID-19: Survey
WebMD collected and analyzed more than 2000 responses to an online reader survey about wearing masks.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 7, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

Antifungal and antidepressant drugs may help protect against COVID-19
(Wiley) New research published in the British Journal of Pharmacology indicates that two currently available medications--an antifungal drug and an antidepressant--can effectively inhibit the virus that causes COVID-19 in laboratory cells. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - April 7, 2021 Category: Infectious Diseases Source Type: news

Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis
NEW YORK--(BUSINESS WIRE) April 07, 2021 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil
Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000,& Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) in (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: PremierZen Black 5000 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use PremierZen Black 5000, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Triple SupremeZen Gold 3500 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Triple SupremeZen Gold 3500, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Imperial Extreme 2000 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Imperial Extreme 2000, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Thumbs Up 7 Red 70K contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Thumbs Up 7 Red 70K, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Thumbs Up 7 Blue 69K contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Thumbs Up 7 Blue 69K, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Shogun-X Black contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Shogun-X Black, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Red Spartan 3000 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Red Spartan 3000, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: April 6, 2021
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Hot Rod contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Hot Rod, 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 - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cardiovascular Risks Elevated in Transgender Youth Cardiovascular Risks Elevated in Transgender Youth
A multicenter study shows increased risk for some cardiovascular and metabolic outcomes. The causes not well understood.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 6, 2021 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology News Source Type: news

Prostate Cancer: Symptoms, Tests, and Treatments
Prostate cancer is the most common cancer among men and the second most common cause of cancer-related deaths among American men. Learn more about the disease ’s symptoms, tests, and treatments. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Neoingenium Labs, SA de CV - 610499 - 03/31/2021
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

RPK Pharmaceuticals Inc. - 613400 - 03/26/2021
Failure to Comply with Drug Listing Requirements/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 6, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Kanuma (sebelipase alfa)
Title: Kanuma (sebelipase alfa)Category: MedicationsCreated: 4/6/2021 12:00:00 AMLast Editorial Review: 4/6/2021 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - April 6, 2021 Category: Drugs & Pharmacology Source Type: news

Butrans (buprenorphine)
Title: Butrans (buprenorphine)Category: MedicationsCreated: 4/6/2021 12:00:00 AMLast Editorial Review: 4/6/2021 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - April 6, 2021 Category: Drugs & Pharmacology Source Type: news

About 1 in 5 Clinicians Considers Quitting Due to Pandemic: Survey About 1 in 5 Clinicians Considers Quitting Due to Pandemic: Survey
A large survey at an academic medical center adds evidence to the toll the COVID-19 pandemic is taking on some clinicians.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 6, 2021 Category: Drugs & Pharmacology Tags: Infectious Diseases News Source Type: news

QMART Issues Voluntary Nationwide Recall of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 Due to Presence of Undeclared Sildenafil and/or Tadalafil
Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000& IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil a (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Genetic Risk Factors for Cirrhosis in Hemochromatosis Genetic Risk Factors for Cirrhosis in Hemochromatosis
This study identified gene variants which modulate the cirrhosis risk in hereditary hemochromatosis.Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 5, 2021 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news