The Pharma Data

JANUARY 26, 2021

. With very limited approved first-line pharmaceutical therapies for HCC available today, challenges include drug resistance, adverse side effects, and high costs. billion by 2027. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9

FDA 40

FDA Treatment Small Molecule Drugs 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority B List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. The study evaluated the safety and efficacy of two doses of abrocitinib, 100 mg and 200 mg, versus placebo in adults with moderate to severe atopic dermatitis who were on background topical therapy. Patent Term Extension certificate extending the term of U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40