First-ever rapid-acting insulin. This approval extends to a 3-milliliter single-patient-use prefilled pen and a 10-milliliter ...

Here to help break down this new painkiller is Dr. Sean Mackey. He’s a Professor of Anesthesiology and Medicine at Stanford ...

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...

The U.S. Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active ...

The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...

The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved and the third insulin product approved by the FDA.

Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis ...

GSK's Penmenvy wins FDA approval to protect against five meningococcal serogroups. The CDC panel will vote on usage ...

The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...