ANI Pharmaceuticals announces FDA approval for expansion of Iluvien label
ANI Pharmaceuticals (ANIP) announced that the U.S. FDA has approved an expanded label for Iluvien that includes an indication for the treatment ...
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 ...
JD Supra9d
IP Hot Topic: Senate Bill Seeks to Create New Skinny Label Protections
A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection ...
Lipocine announces FDA labeling changes for testosterone products
Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...
MyChesCo on MSN4d
FDA Approves Lifesaving Stroke Drug, Xarelto Generics, and Issues Urgent Testosterone Warnings
The U.S. Food and Drug Administration (FDA) has released several important updates addressing new medication approvals and ...
GlobalData on MSN10d
Genentech wins FDA approval for second stroke treatment
Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.
The American Journal of Managed Care7d
FDA Expands Furosemide Injection Label to Treat Edema in CKD
Furosemide injection was previously approved to treat congestion from fluid buildup in adults with chronic heart failure.
Medscape7d
How Many Patients in Early Cancer Trials Get Drugs Ultimately Approved by FDA?
Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and ...
BioSpace10d
BeiGene Gets Yet Another Label Expansion for PD-1 Drug Tevimbra
The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the ...