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Filsuvez Topical Gel Gets FDA Approval for Epidermolysis Bullosa

XTalks

Filsuvez topical gel is a sterile botanical drug product designed for topical use, containing birch triterpenes within an oil base. Upon Vyjuvek’s entry into cells, the vector genome is integrated into the nucleus, initiating the transcription of the encoded human COL7A1.

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First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Head and Neck Squamous Cell Cancer.

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

The Pharma Data

Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Head and Neck Squamous Cell Cancer.

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Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

VP-102 is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidim delivered by way of a single-use applicator. Quantum Genomics launched its Phase III REFRESH trial in difficult-to-treat or resistant hypertension. BT-001 is based on the patented Invir.IO

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Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. endocrinopathies and dermatologic reactions) are discussed below.

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Bristol Myers Squibb Statement on Opdivo® (nivolumab) Hepatocellular Carcinoma U.S. Indication

The Pharma Data

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. endocrinopathies and dermatologic reactions) are discussed below.

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CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. Immune-Mediated Skin and Dermatologic Adverse Reactions.

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