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
The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.
July 17, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The announcement included updates on Elevidys’ label changes for Duchenne muscular dystrophy treatment. It also announced an update regarding its Elevidys label changes for Duchenne muscular dystrophy (DMD) treatment. Credit: luchschenF/Shutterstock.com.
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.
The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. Broad label questioned. billion in 2027.
355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.
Qulipta (atogepant) is already approved for prevention of episodic migraine – where attacks are less frequent – getting the green light from the FDA last September for this use a few months after Biohaven and Pfizer’s Nurtec ODT (rimegepant). The post AbbVie files Qulipta for chronic migraine prevention appeared first on.
Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.
Qulipta was approved by the FDA last September for the preventive treatment of episodic migraine, a few months later than its main rival in the oral CGRP category, Biohaven’s Nurtec ODT (rimegepant), got a green light for the same indication. billion by 2027.
In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. weight reduction in obese individuals, as per its label. Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro.
New drugs for immunological and inflammatory diseases feature prominently among new product launches this year that could top $1 billion in annual sales by 2027 or be clinical “game changers,” according to Clarivate.
In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. weight reduction in obese individuals, as per its label. Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro.
Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020.
While Lumigan is a 0.01% solution of bimatoprost and no generic product is manufactured at this concentration, patents on Lumigan expire in 2025 and 2027, so there may be a generic option approved by the Food and Drug Administration (FDA) thereafter. Generic bimatoprost drops are available at a 0.03% concentration currently.
Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. GlobalData is the parent company of Pharmaceutical Technology.
Snow & Riëtte van Laack — Two southern states are taking bold steps to change the way they approach food labeling—and they’re not mincing words. Texas Goes BIG on Food Warnings Beginning on January 1, 2027, Texans may notice new warning labels on some food products sold in their fair state. By Charles D. Synthetic dyes.
The FDA first approved vortioxetine to treat major depressive disorder in 2013. That might differ slightly in the US, but even when the Trintellix patent ends in 2026, its generic probably wont debut until 2027 or later. What are the off-label uses for Trintellix? So some doctors prescribe it off-label for anxiety as well.
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