FDA approves mepolizumab (Nucala; GSK) as the first monthly biologic for chronic obstructive pulmonary disease (COPD), significantly reducing exacerbations in patients with an eosinophilic phenotype.

Samsung Biologics Co., a biotech arm of South Korea's Samsung Group, said Thursday it plans to spin off its biosimilar ...

South Korean drug maker Samsung BioLogics said on Thursday it plans to split its business into contract manufacturing and development companies, to help allay customer concerns about conflicts of ...

Samsung Biologics Co. said it plans to carve its business into a contract drug manufacturer and a holding firm which will ...

FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone ...

Ampion is a biologic drug based on a blood-derived cyclised peptide and small molecules that target multiple pathways in the innate immune response characteristic of inflammatory disease.

US President Trump signed an executive order on May 5 to rebuild US prescription drug manufacturing, with a focus on reducing reliance on foreign-made medicines, directing to accelerate facilities ...

Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic ...

Biologics are targeted medications made with the help of living cells. The cells produce the proteins that are used to make the drug. This is different from traditional pharmaceutical drugs, which are ...

A partial phase out of a top insulin product by Danish drug maker Novo Nordisk may open a bounty for Eris Pharma and its manufacturing partner Biocon Biologics. “It is a small emergency,” says Amit ...

FDA approves Teva and Alvotech's Selarsdi as an interchangeable biosimilar to Stelara, supporting the treatment of multiple chronic inflammatory diseases.

Kinlytic is already approved for clinical use in the U.S. and the parties’ work is to validate new manufacturing for the drug and to re-enter the market by way of a supplemental biologics ...