
Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer patients eligible for treatment with Ziihera.

The educational platform is targeted at HCPs and their staff.

The actor is part of a campaign for early colon cancer screening.

Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.

The results say that the industry still lacks talent and skills in this area.

The campaign also includes partnerships with other celebrities, including Lance Bass and Retta.

Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer, addressing a critical unmet need with promising efficacy and improved quality of life.

Dorman previously served as head of Gilead Sciences’ U.S. Oncology Unit.

The drug, developed by UCB, is approved to treat adults with the inflammatory skin disease.

Former Chief Oncology Officer and Executive Vice President, Chris Boshoff, MD, PhD, will assume the role and lead all R&D functions including oncology.

The latest news for pharma industry insiders.

Ron Lanton, Partner, Lanton Law, discusses ways that the recent FDA PD-1 inhibitor label restrictions could influence future drug development strategies.

Ron Lanton, Partner, Lanton Law, discusses potential challenges that will come as a result of the FDA’s recent move to tighten label restrictions on PD-1 inhibitors for gastric cancers.

Syndax describes the drug as the first of its kind.

The news is part of the organization’s goal of demonstrating a commitment to women’s health.

Ron Lanton, Partner, Lanton Law, discusses why the regulatory body made the decision to place restrictions on PD-1 inhibitors for gastric cancers.

The contest focused on telling the stories of how migraines impacted patients’ careers.

As the first major treatment to be approved for schizophrenia in over 30 years, Cobenfy is poised to set the stage for new approaches in treating mental health disorders.

The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.

Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino acid decarboxylase deficiency.

The survey is part of an initiative from GSK to improve these gaps.

The company will also change its NASDAQ ticker to ONC.

Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity.

Under terms of the collaboration, Merck will lead the development, manufacturing, and commercialization of LM-299, an investigational bispecific antibody.

Results from the Phase III KOMET trial found that Koselugo demonstrated a statistically significant objective response rate compared to placebo treating plexiform neurofibromas.

As part of the acquisition, BioNTech will obtain the rights to BNT327/PM8002, a bispecific antibody that targets PD-L1-low and -negative tumors that often resist checkpoint inhibitors.

Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a previously withdrawn application to the FDA for nonsquamous non-small cell lung cancer.

Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Familial Chylomicronemia Syndrome is a rare condition that can have deadly symptoms.

Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint of reducing Positive and Negative Syndrome Scale scores after six weeks of treatment for schizophrenia.