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

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. Priority B List. primary and secondary).

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. In March 2021, Pfizer and BioNTech announced that the European Medicines Agency (EMA) approved storage of BNT162b2 at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 40