Tag: FDA

Ascendis Pharma's Yorvipath Cleared by FDA After Initial Hurdles. Credit | Reuters

Ascendis Pharma’s Yorvipath Cleared by FDA After Initial Hurdles 

United States – Danish drugmaker Ascendis Pharma said in a statement that the US Food & Drugs Administration had green-lighted its therapy for adult patients with hormone disorders, and its shares rose by over 10 percent in the premarket trade, ...

Revolutionary Cancer Treatment Tecelra Receives FDA Approval. Credit | Getty Images

Revolutionary Cancer Treatment Tecelra Receives FDA Approval 

United States – A new immunotherapy has been approved to treat mesothelioma – a rare type of cancer that affects soft tissues and is most often diagnosed in young men. Tecelra (afamitresgene autoleuecel) has been approved for synovial sarcoma, which ...

FDA Prohibits BVO in Sodas Citing Safety Risks. Credit | Getty Images

FDA Prohibits BVO in Sodas Citing Safety Risks 

United States – FDA has recently implemented an outright prohibition on the use of a specific soda additive, which will begin next month, on account of health risks.  New Regulation  On Tuesday, the FDA explained that it disqualified the regulation ...

FDA Pauses Approval for Rocket Pharmaceuticals' Kresladi Therapy. Credit | Dreamstime

FDA Pauses Approval for Rocket Pharmaceuticals’ Kresladi Therapy 

United States – The US health regulator has not cleared gene therapy by Rocket Pharmaceuticals (RCKT. O) to treat a deadly and rare pediatric autoimmune syndrome that attacks the immune system.  New Jersey-based company stocks dropped more than 13% to ...