2027, Marketing and Pharmacokinetics

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. The certificate extends the term of U.S. About Pfizer Oncology.

Clinical Trials

Clinical Trials Treatment Therapies Production

Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Agency IQ

MAY 17, 2024

Ultimately, industry is wagering that increased regulatory efficiency—which it pays for—will benefit its products through faster review times, more certainty and more time on the market for its products. GDUFA III), which reauthorized the program through 2027. The generic drug user fee program is currently on its third iteration (i.e.,

Science

Science FDA Drugs Production

Drug Discovery Digest

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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