Despite finally winning a hard-fought FDA approval for its chronic kidney disease (CKD) anemia drug Vafseo last year, Akebia ...

Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.

Patients enroll in phase 2 oncology trials seeking access to promising new treatments, but the risk-benefit assessments and ...

The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on ...

The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...

Furosemide injection was previously approved to treat congestion from fluid buildup in adults with chronic heart failure.

Compounded versions of popular drugs used for weight loss including Wegovy and Zepbound will soon no longer be available ...

Genentech’s label expansion for TNKase consolidates its market position for pharmacological stroke treatments.

The FDA approved expanded prescribing information for Izervay for the treatment of geographic atrophy secondary to age-related macular degeneration. The label update follows the company’s ...

ALK announced that the U.S. FDA expanded its indication of Odactra for the treatment of house dust mite-induced allergic rhinitis, with or ...