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

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

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

Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating ...

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 ...

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 ...

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 ...

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

For now, however, the Prevnar brand remains largely unscathed from Merck's challenge. Vaxneuvance was launched after Pfizer introduced Prevnar 20, but debuted with FDA approval for paediatric use ...