PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998.

Treatment 52

Treatment FDA Approval DNA Small Molecule 52

Advarra

JANUARY 11, 2024

After injection of such a vaccine, the mRNA instructs cells to produce proteins designed to stimulate an immune response against these same protein targets when they show up in viruses or in tumor cells. Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.

Vaccine 52

Vaccine Therapies Clinical Trials Small Molecule 52

The Pharma Data

MAY 7, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

Vial

DECEMBER 11, 2023

The Food and Drug Administration (FDA) approved and recommended dozens of small-molecule drugs. Related but genetically diverse virus variants can occur within the same infected patient, which may lead to quasispecies and resistance to antibody and T-cell-mediated immune responses.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

PerkinElmer

NOVEMBER 9, 2022

These cells overexpress PD-L1, leading to inhibition of cytotoxic T-cells by binding to the PD-1 receptor on activated T-cells, and subsequent evasion of an immune response. To date, the only FDA approved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs).

Small Molecule 52

Small Molecule Research Immune Response FDA Approval 52

The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition.

Therapies 52

Therapies Clinical Trials Production Treatment 52

The Pharma Data

DECEMBER 11, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Germany, Turkey, South Africa, Brazil and Argentina. Source: Pfizer Inc. .

Vaccine 52

Vaccine Clinical Trials Trials Licensing 52