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FDA approves bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy for the treatment of sickle cell disease, which affects approximately 100,000 people in the United States.

Lyfgenia, Casgevy Become First Cell-Based Gene Therapies to Gain FDA Approval for Sickle Cell Disease

Novartis anticipates Fabhalta to be available in the United States in December for the treatment of paroxysmal nocturnal hemoglobinuria. 

Fabhalta Gains FDA Approval for Treatment of Paroxysmal Nocturnal Hemoglobinuria 

Johnson & Johnson’s TAR-200 has a novel targeted releasing system that allows for a controlled release of gemcitabine in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

Investigational Treatment for High-Risk Bladder Cancer Awarded FDA Breakthrough Designation

Opdivo (nivolumab) plus cisplatin-based chemotherapy shows improved survival benefits in the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Opdivo Combination Granted FDA Priority Review for Unresectable, Metastatic Urothelial Carcinoma

Jaypirca (pirtobrutinib) is indicated for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who received at least two prior lines of treatment with a Bruton tyrosine kinase inhibitor and a BCL2 inhibitor.

FDA Grants Pirtobrutinib Accelerated Approval for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma 

Ongoing clinical trials are evaluating zotatifin (eFT226) plus Faslodex (fulvestrant) and Verzenio (abemaciclib) for the treatment of ER–positive, HER2-negative advanced or metastatic breast cancer. 

Triplet Combination for Breast Cancer Gets FDA Fast Track Designation

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

FDA Priority Review Granted to Keytruda/Padcev Combo for Locally Advanced, Metastatic Urothelial Carcinoma

In clinical trials, roflumilast cream demonstrated rapid and sustained improvement in the signs and symptoms of atopic dermatitis in patients 6 years of age and older.

Arcutis Biotherapeutics Seeks FDA Approval for Roflumilast in Atopic Dermatitis 

In clinical trials, KarXT (xanomeline-trospium) demonstrated a combination of strong tolerability and clinically meaningful symptom reduction in adult patients with schizophrenia.

FDA to Evaluate Novel Treatment for Schizophrenia 

The approval of Ogsiveo represents an important therapeutic advance for patients with progressing desmoid tumors requiring systemic treatment.

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