Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.
All posts by admin
FDA approves Mylotarg for treatment of acute myeloid leukemia
The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial, Due to a Lack of Sterility Assurance
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.
Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia.
Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.
Dedinas Franzak Enterprises Issues Allergy Alert On Undeclared Milk In "Butter Flavored Popcorn"
Dedinas Franzak Enterprises of Grand Rapids, MI, is recalling several brands of butter flavored popcorn because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Rajbhog Distributors GA Inc. Issues Allergy Alert on Undeclared Almonds in JALEBI
Rajbhog Distributors GA. Inc. of Tucker GA-30084 is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs. People who have an allergy or severe sensitivity to Almonds run the risk of serious or life- threatening allergic reaction if they consume these products.
FDA approval brings first gene therapy to the United States
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.