Both ANI Pharmaceuticals ANIP and Teva Pharmaceuticals TEVA operate in the pharmaceutical sector, focusing on generic and ...

The Association for Accessible Medicines and its Biosimilars Council have released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

CivicaScript, a nonprofit generic drug company, has launched insulin glargine-yfgn and ustekinumab-aauz, expanding its national portfolio of low-cost treatments. The insulin product, which is ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

Pharma major Biocon is set to announce its Q3FY26 results on 12 Feb 2026. Brokerage reports project a strong Q3FY26 for ...

With the first biosimilar approved by the US Food and Drug Administration (FDA) in March and a second approval likely in the next few months, practical and operational challenges are already starting, ...