Ocaliva, approved for primary biliary cholangitis, faced FDA warnings and restrictions after postmarket data showed higher ...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug ...

Robert F. Kennedy Jr., who's nominated to become the next health secretary, asked the federal government to revoke its authorization of all COVID-19 vaccines in May 2021, just as vaccinated Americans ...

Eight years after it was established partly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only ...

New federal guidelines may limit Covid vaccine access for millions in multiple states. Here are the states affected.

The Food and Drug Administration on Wednesday restricted access to COVID-19 vaccines by ending their emergency authorization and refining eligibility standards to exclude most healthy adults and ...