The agency is planning a new review process that could result in ingredient bans or additional labeling requirements, ...

The Food and Drug Administration will soon “unleash a massive framework” for how vaccines are tested and approved.

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable ...

MiscellaneousFormycon and Fresenius Kabi announce FDA Approval of Interchangeability for FYB202/Otulfi® (ustekinumab-aauz) 19.05.2025 / 15:00 CET/CESTThe issuer is solely responsible for the content ...

The FDA originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was highly similar to Stelara.

RFK Jr. pledged not to upend US vaccine system, but big changes are underway. It's unclear which shots will be available.

Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as ...

The Janus Henderson Global Life Sciences Fund returned 0.99% and the MSCI World Health Care IndexSM returned 5.10% for Q1 ...

Breakthrough approval highlights the power of AIM’s next-gen platform and global ambition in biotech innovation.

Diphenhydramine is the active ingredient in countless over-the-counter medications. But experts say there are serious risks ...

Revolutionizing Alzheimer's care, Zunveyl minimizes GI and sleep side effects. Discover its market potential and why it's ...

Former Visalia doctor Stephen D. Meis pleaded guilty to introducing misbranded drugs into interstate commerce, including a treatment for COVID-19 that was sold to practitioners and public ...