Drug Target Review
APRIL 7, 2025
The parallel evolution of novel therapies, biomarker endpoints and regulatory evolution may signal a new paradigm for clinical drug development over the coming years. Silver Spring (MD): Food and Drug Administration (US); 2016-. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics.
Drug Target Review
JULY 4, 2023
The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 Translational and Clinical Pharmacology [Internet]. 2022 [cited 2023 Feb 10];30(2):71.
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New Drug Approvals
SEPTEMBER 13, 2024
2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]
The Premier Consulting Blog
JUNE 18, 2023
This reflects the FDA’s long history of reviewing submissions that implement CM&S across a broad range of areas, including quantitative clinical pharmacology, dose-response modeling, benefit-risk assessment, complex innovative designs and disease modeling/trial simulation.
Agency IQ
SEPTEMBER 15, 2023
In August 2016, the CHPA provided a lengthy comment asserting, essentially, that the petitioners had already sought relief in its earlier petition and that the Nonprescription Drugs Advisory Committee (NDAC) had addressed the concerns raised again in this latest petition. The two sides saw nearly every finding in a different light.
Agency IQ
DECEMBER 11, 2023
Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”
Agency IQ
FEBRUARY 23, 2024
This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.”
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