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

The Pharma Data

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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Q&A: How a partnership between physicians and researchers aims to make cancer drugs safer

Broad Institute

Earlier this year, the researchers shared their first translational results, describing the immune cell response underlying colon inflammation in patients undergoing ICI therapy. These are home-run, breakthrough therapies, and quite an amazing success story. How did you go about launching this effort?

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

The Pharma Data

The FDA approved it under the brand name Gavreto on September 4. The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. The drug was approved for that indication on November 13.

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FDA Approves

The Pharma Data

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., In the U.S.,

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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 A one-time gene therapy injection for spinal muscular atrophy. Gene Therapy. Nature Neuroscience. Read You love to see it! Trends in Biotechnology. ” Max Bayer.

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

The Pharma Data

Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. After a median follow-up of 13.4

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

The Pharma Data

” In May 2020, Lilly’s first-in-class selective RET inhibitor Retevmo received Accelerated Approval from the U.S. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50