The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. About Pfizer Oncology.

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

Treatment 100

Treatment Pharmacokinetics Drugs Cell Biology 100

Agency IQ

MAY 17, 2024

GDUFA III), which reauthorized the program through 2027. For the in vivo portion, the guidance states that applicants should conduct: 1) An in vivo pharmacokinetics (PK) study in fasting condition for both product strengths with healthy volunteers, and 2) an in vivo comparative clinical endpoint or pharmacodynamic (PD) study with patients.”

Science 40

Science FDA Drugs Production 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be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary). primary and secondary).

FDA 40

FDA Science Biosimilars Clinical Trials 40