FDA Commissioner Marty Makary was met with a skeptical set of Senate appropriators Thursday when he testified on his agency’s ...

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

Pfizer faces several headwinds, including patent cliffs, regulatory risks, and a setback in obesity drug development. Click ...

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...

The labelling puts it in direct contention with Pfizer's ... include pursuing regulatory approvals outside the US, starting with Europe – where it has already filed the drug, with a decision ...

The U.S. FDA has approved Novavax's COVID-19 vaccine, Nuvaxovid, for older adults and those aged 12 to 64 at risk of severe illness. Despite missed deadlines and regulatory challenges, the approval is ...

U.S. regulators will no longer approve COVID booster shots for healthy adults and children without new studies, adding a ...

The Global Nanomedicine Market is expected to witness a growth rate of 10-12% in the next five years. Ongoing research and ...

NEW YORK - Pfizer Inc. (NYSE:PFE), a pharmaceutical giant with $62.46 billion in revenue and a market capitalization of $130.76 billion, has secured an exclusive licensing agreement with Chinese ...

Elaine Chen covers biotech, co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud.