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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...

First FDA approved Drug Treatment for Smallpox

Tecovirimat (TPOXX) is the first FDA approved drug treatment of smallpox. In 1980, WHO declared that smallpox was eradicated; however, tecovirimat was developed as a counter to the possible use of smallpox as a bio-weapon. It is the first product awarded a Material...

Nipah Virus Outbreak in India

On May 19, an outbreak of the Nipah virus (NiV) has lead to 17 confirmed deaths in the Kozhikode District, Kerala State, India. Two thousand people, including health care workers, are currently under observation. WHO South-East Asia Region has declared Nipah as an...

S. 204 “Right to Try Act” Signed

Today, May 30, 2018, Trump signed S. 204, the “Right to Try Act,” giving the terminally ill more access to treatments outside of clinical trials. The Right to Try is intended to help patients, particularly cancer patients, who are not enrolled in clinical trial...