The FDA approved cemiplimab-rwlc (Libtayo)

The FDA approved cemiplimab-rwlc (Libtayo) for treatment of locally advanced, or metastatic, cutaneous squamous cell carcinoma (CSCC). This is the first drug treatment approved for advanced CSCC, the second most common cancer in the U.S. Please see the FDA website for...

FDA Approves First Generic EpiPen (epinephrine)

The FDA has approved the first generic version of Mylan’s EpiPEN and EpiPen Jr (epinephrine) auto injector used to treat emergency allergic reactions, such as the life-threatening anaphylaxis. The generic epinephrine auto-injector has been green flagged to market in...

First FDA Approved Targeted RNA-based Therapy

The U.S. FDA approved the first of its kind targeted RNA-based therapy Onpattro (patisiran) to treat peripheral nerve disease (polyneuropathy) caused from hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA approved treatment...