Each episode of this journey through a disease state contains both a physician guide and a downloadable/printable patient ...

In 2022 the Supreme Court corrected a grave error and overturned Roe v. Wade. Many states quickly enacted laws to protect women and unborn children from abortion or allowed preexisting pro-life laws ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

Understanding biosimilars, biologics, and the challenges surrounding their regulation and pricing in the pharmaceutical ...

Clinical validation of the Azymetric platform is demonstrated by the accelerated approval of Ziihera® (zanidatamab-hrii), a ...

On Dec. 6, 2024, the FDA released draft guidance, marking a significant development in the regulatory framework for therapies approved under ... of any monoclonal antibodies, including Aduhelm ...

Bentracimab is an investigational human monoclonal antibody fragment that binds to ticagrelor, an oral P2Y 12 platelet inhibitor, reversing its antiplatelet effects. The BLA submission is ...

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

The company submitted its proposal to manufacture and market dengue monoclonal antibody (recombinant ... for considering the approval under accelerated approval process, as per the Second Schedule of ...

This partnership comprises a technology transfer of the current drug product manufacturing process for the Chikungunya ...