Compounded Wegovy and Zepbound may disappear under new FDA rules
The end of compounded versions of weight-loss drugs is near, leaving patients scrambling for alternatives. Some “copycat” ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for ...
Managed Healthcare Executive1d
FDA Approves First Generics of Xarelto
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
PharmaTher Receives US FDA Approval Goal Date for Ketamine
“I am very pleased with the new FDA approval goal date of June 4, 2025 for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to ...
Instylla Completes Submission of Premarket Approval Application for Embrace™ Hydrogel Embolic System
Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) ...
Food Safety News3d
FDA employees now lack the tools to do their jobs
Many critical functions of the food division of the Food and Drug Administration have been drastically slowed or entirely stopped since late ...
News-Medical.Net3d
Breakthrough drug combination targets KRAS mutation in lung cancer
A breakthrough in lung cancer treatment may be on the horizon. Scientists at VCU Massey Comprehensive Cancer Center have uncovered a powerful combination therapy leveraging sotorasib-an FDA-approved ...
Medscape7d
As Trump Administration Probes Long-Approved Medications, Could FDA Revoke Approvals?
A new federal commission will ‘investigate’ decades-old mental health as well as weight loss drugs, prompting concerns from ...
Aquestive Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science ...
Medical News Today14d
How to Get Zepbound: Where to Safely Buy Zepbound Online and What to Know
Off-label means that a doctor prescribes a medication for a reason or at a dose that the Food and Drug Administration (FDA) has not approved. Learn more about how to get Zepbound from LillyDirect ...
STAT15d
There’s a better way to get drugs on the market: progressive approval
Perakslis is a medical and privacy researcher and has served in the FDA ... in drug regulation and the costs of medicines. They are right to do so. Companies want to see products approved faster ...
NJBIZ16d
Drug compounders sue FDA over Novo Nordisk’s Ozempic, Wegovy (updated)
Drug compounders aren’t ready to give up their ability to produce off-brand versions of Novo Nordisk’s weight-loss drug Wegovy and diabetes treatment Ozempic without a fight. An industry group ...