Remove Disease Remove FDA Approval Remove Research Laboratories
article thumbnail

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

article thumbnail

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

The Pharma Data

The FDA approved it under the brand name Gavreto on September 4. PAH is a chronic, progressive disease caused by the hardening and narrowing of the pulmonary arteries that can cause right heart failure and eventual death. The drug also received Rare Pediatric Disease Designation for these indications. Source link.

FDA 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

article thumbnail

Codon Digest: Injected Gene Editors

Codon

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. Read “Nanoscope's phase 2 win for gene therapy shows potential of light-sensitive approach to eye disease.” Nature Neuroscience. Read You love to see it!

DNA 52
article thumbnail

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. www.lilly.com?and?www.lilly.com/news.?P-LLY.

article thumbnail

The Promise of Gas Vesicles

Codon

Dr. Karl Dussik, an Austrian physician, was among the first to suggest that ultrasound could be used to diagnose diseases within the body in 1941. By 2016, Shapiro had set up a research laboratory at the California Institute of Technology in Pasadena and began to devote his attention entirely to gas vesicles.

article thumbnail

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

The Pharma Data

This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease.