All News

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.

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.

The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.

The campaign is focused on providing guidance for newly diagnosed patients.

Agents were informed that they would no longer receive commissions for select signs up as of November 1.

In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.

Submissions to the FDA and EMA for new indication of Darzalex Faspro are based on results of the Phase III Aquila trial in patients with high-risk smoldering multiple myeloma.