This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
After finding a “cascade of failures” at a manufacturing plant run by a key chemotherapy supplier, the Food and Drug Administration will not allow the company to resume distribution in the U.S. beyond some cancer medicines that are in short supply.
FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.
Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility. These serious violations of manufacturing protocols were revealed in a July 28 warning letter sent by the U.S.
The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. ” While ODAC could still decide to back the drug at the meeting, the FDA isn’t beholden to follow its experts’ advice.
The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 1942 – Chemotherapy moves from trenches to treatment . Before the birth of bone marrow transplants, patients were often treated using chemotherapy, which could be used to kill cancer cells.
On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.
The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.
Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options.
AstraZeneca’s BTK inhibitor Calquence has become the first targeted oral therapy to be backed by NICE for NHS England patients with chronic lymphocytic leukaemia (CLL) who can’t be treated with first-line chemotherapy. The decision is at odds with the situation in Scotland, where Nilemdo was turned down in December.
Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 30 June 2016.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content