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Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says.

Results from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

The company announced that it will conduct research based on guidance from the agency.

Ouva’s AI-powered technology will be added to AvaSure’s digital platform.

Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.

Leqselvi is classified as a novel oral Janus Kinase inhibitor that targets JAK1 and JAK2 pathways, thought to be involved in the autoimmune response that leads to alopecia areata.

The company plans to develop these treatments using it’s AI-powered platform.

MGI Tech Co. issued a statement detailing the use of its technology in improving the rates of genomic sequencing in South Africa.

FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.

The supplemental New Drug Application for brexpiprazole in combination with sertraline is supported by data from three randomized clinical trials that evaluated its safety and efficacy in adult patients with post-traumatic stress disorder.

Expanded indication of Brineura allows for treatment of neuronal ceroid lipofuscinosis type 2 disease in both symptomatic and presymptomatic children.

A single dose of giroctocogene fitelparvovec significantly reduced the mean total annual bleeding rate in patients with moderately severe to severe hemophilia A.

The latest news for pharma industry insiders.

Moving forward, Sage Therapeutics and Biogen intend to cease further clinical development of SAGE-324 for essential tremor.

Results of the PURPOSE 1 trial indicated that treatment with lenacapavir was superior to Descovy and Truvada.

The PBM defined its core values and what role it believes PBMS should play in the industry.

The trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors.

The new approval expands Xeomin’s indications to include horizontal forehead lines and lateral canthal lines.

Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.

The company received the money through a government project agreement.

JAMA study aims to determine whether financial barriers impact access to mental health services.

Dx&Vx identified multiple potential drug candidates using AI-based technology.

The two companies will continue to collaborate on the use of machine learning in improving precision medicine development.

This is the latest approval for Phathom Pharmaceutical’s GI treatment.

Novel drug 7MW3711 binds to tumor cell membrane antigens, being internalized and transported to the lysosome, releasing a cytotoxic drug, and inducing tumor cell apoptosis.

Treatment with CT-996 led to a significant placebo-adjusted mean weight loss of 6.1% within four weeks in participants with obesity but without type 2 diabetes.

The tech company’s data platform will be implemented into the genomic research department’s workflow.

The network includes organizations that represent over 45,000 agents and brokers.