FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer
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 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Stresses Critical Importance of Safe Disposal of Medications Ahead of National Prescription Drug Take Back Day
For many years, the U.S. Food and Drug Administration has strongly supported work to expand the availability of drug take back programs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 22, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lo que debe saber sobre el c áncer colorrectal
El c áncer colorrectal se puede prevenir y si se lo detecta a tiempo, se puede tratar. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 21, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

BD Announces the Voluntary Recall of Specified Lots of ChloraPrep ™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator
BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep ™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Hou Fu Biotech - 611644 - Jiangsu Co., Ltd
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 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer
Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 17, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
Today, the FDA revoked the emergency use authorization that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Triple SupremeZen Plus 3500 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use SupremeZen Plus 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Triple SupremeZen Extreme 3500 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Triple SupremeZen Extreme 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Thumbs Up 7 White 11K contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Thumbs Up 7 White 11K, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Thumbs Up 7 Black 25K contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Thumbs Up 7 Black 25K, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Shogun-X Platinum 7000 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or Shogun-X Platinum 7000, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Rock Steady 72 Hours contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Rock Steady 72 Hours, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: April 16, 2021
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Premier Platinum 5000 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Premier Platinum 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: PremierZen Extreme 3000 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use PremierZen Extreme 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Original White Dragon contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Original White Dragon, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Krazy Night contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Krazy Night, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Kopi Jantan Tradisional Natural Herbs Coffee contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Kopi Jantan Tradisional Natural Herbs Coffee, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Imperial Platinum 2000 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Imperial Platinum 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Imperial Gold 2000 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Imperial Gold 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma
Hematology / Oncology (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: Burro en Primavera 60000 contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Burro en Primavera 60000, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: 69MODE Blue 69 contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use 69MODE Blue 69, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Public Notification: 3 KO Gold XT contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use 3 KO Gold XT, 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 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA-ASCO Hematology and Oncology Fellows Day Workshop - 05/07/2021 - 05/07/2021
FDA-ASCO Hematology and Oncology Fellows Day Workshop (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Compounding MOUs
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cipher Pharmaceuticals Inc. - 11/30/2017
False& Misleading Claims/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. - 04/24/2019
False& Misleading Claims/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Avanthi, Inc. - 09/28/2018
False& Misleading Claims/Misbranded (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Trinity Natural Health & Pain Management, Inc. - 614007 - 04/13/2021
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 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19
FDA releases guidance on how remote interactive evaluations will be requested by FDA and conducted for the duration of COVID-19 at drug facilities. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency 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 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA/CDER and AASLD 2021 DILI Conference XVIII - 04/20/2021 - 04/22/2021
Virtual meeting: Online (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 14, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer
FDA granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Topical Dermatologic Corticosteroids: in Vivo Bioequivalence
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

La FDA advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina causan graves da ños
La Administraci ón de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de EE. UU. advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina, de venta libre (OTC, por sus siglas en inglés), pueden provocar graves daños, incluidos problemas cardíacos y de salud mental. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: April 13, 2021
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mifeprex (mifepristone) Information
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Proquimes S A Productos Quimicos Especializados S.A. - 610069 - 04/05/2021
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

MYM Hidrominerales S.A. de C.V. - 610066 - 04/09/2021
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 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Roque Plast S.A. de C.V. - 609492 - 04/09/2021
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 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Maison Terre, LLC - 610315 - 04/01/2021
Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 13, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Study Data Technical Rejection Criteria (TRC): What you need to know! - 05/21/2021 - 05/21/2021
FDA is planning to implement eCTD validations in 2021 specific to submissions containing study data. FDA published the TRC to assist industry in understanding when a submission containing study will be subject to these study data eCTD validations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 12, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil
NS NY Distributor Inc is voluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5) (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 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