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Approval marks the first time an immuno-oncology regimen has demonstrated a survival benefit for all adults with primary advanced or recurrent endometrial cancer, company says.

IDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small cell lung cancer.

Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses.

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical affairs, US oncology business unit, offers his thoughts on the evolution of Lynparza across indications such as breast, prostate, and pancreatic cancers.

Results of the Phase III Clarity AD study found that Leqembi reduced cognitive decline by -0.95 on the Clinical Dementia Rating-Sum of Boxes compared to expected declines in untreated groups.

Results from the PERSEUS study led to the FDA approval of Darzalex Faspro in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

With a growing number of legal battles over women’s health issues, such as abortion and infertility, stakeholders are concerned about the impact on everything from healthcare access to new technology.

The report also details steps that employers are taking to manage the cost of healthcare plans for employees.

The latest news for pharma industry insiders.

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 study is expected to evaluate the safety of Iomab-ACT in sickle cell disease patients who are undergoing allogeneic bone marrow transplants.

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.