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 ...

The US Food and Drug Administration (FDA) has approved a new presentation of Alvotech and Teva Pharmaceuticals’ SELARSDI ...

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 ...

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

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

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

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

Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and ...

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