FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027. States’ regulatory regimes have sought to balance a safe framework with the health and safety risks, especially among youth.

Regulations 59

Regulations Production FDA Approval Drugs 59

Drug Target Review

MARCH 20, 2025

“This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted. These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication.

Therapies 52

Therapies Trials Clinical Development FDA 52

The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. RE47,739 for Ibrance by more than four years until March 2027. 7) BNT162b2 has not been approved or licensed by the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40