The FDA has approved a new presentation of Alvotech and Teva’s SELARSDI, for the treatment of ulcerative colitis and Crohn's ...

Novo Nordisk wants the Food and Drug Administration (FDA) to prevent compounding pharmacies from manufacturing their own ...

The US Food and Drug Administration (FDA) yesterday approved Abrysvo (respiratory syncytial virus vaccine). Developed and ...

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Astellas Pharma has gained approval from the US Food and Drug Administration (FDA) for VYLOY (zolbetuximab-clzb), in ...

Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA ...

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which ...

“Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective ...

Pfizer's Hympavzi receives FDA approval as the first anti-TFPI therapy for hemophilia A and B. This subcutaneous, once-weekly ...

Novo Nordisk NVO has appealed to the U.S. Food and Drug Administration (FDA) to halt the production of compounded versions of ...

The FDA has approved Imuldosa, a biosimilar to Stelara (ustekinumab), for the treatment of various chronic inflammatory diseases.