2011, FDA Approval, Pharmacokinetics and Vaccine

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

2011

FDA Approval

Pharmacokinetics

Vaccine

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. ZYTIGA ® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), approved by the U.S.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Trials

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Agency IQ

SEPTEMBER 22, 2023

An AgencyIQ analysis from May 2020 found that a quarter of all New Molecular Entities (NMEs) approved since 2011 had relied upon a single pivotal trial, and that this reliance had remained relatively stable between 2011-2019 despite some year-to-year variability.

FDA

FDA Science Trials Clinical Trials

Drug Discovery Digest

Janssen Presents Results from Phase 3 ACIS

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Stay Connected