Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, today announces a positive opinion from the European Medicines Agency (EMA)’s Committee for ...

It was a busy week in the biotech sector, marked by significant regulatory and pipeline updates. Among these, shares of ...

More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry out expensive clinical efficacy studies, experts have said.

The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

The San Francisco Human Rights Commission works in service of the City’s anti-discrimination laws to further racial solidarity, equity, and healing.