Regulatory

The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.

FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.

The expanded indication for Zynrelef now includes soft tissue and orthopedic surgical procedures.

Theratechnologies said it will address the FDA’s complete response letter and will continue to seek approval for the new formulation of tesamorelin for the treatment of lipodystrophy in patients also diagnosed with HIV.

Severe hypocalcemia was found to be more common among patients with advanced chronic kidney disease with mineral and bone disorder who are taking Prolia for osteoporosis.

New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products.

The device can produce AI-assisted readings.

The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.

Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.

Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising.

Drug companies face new hurdles in a rapidly changing marketplace. How do they finance new drug development amid the uncertainty?

Experts gauge whether the needle is finally moving on the effective structuring of outcomes centered payment agreements—from operational, technology, and acceptance standpoints.

Unprecedented policy and access issues threaten R&D momentum.

National Library of Medicine study emphasizes inadequacies in ensuring the safety and efficacy of over-the-counter dietary supplements.

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.

Fruquintinib (Fruzaqla) is the first novel chemotherapy-free treatment option approved for metastatic colorectal cancer in more than a decade.

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

Company aims to receive approval on a Type II Variation application for Sirturo for patients with pulmonary tuberculosis.

The online promotion of intravenous infusions and oral forms of subanesthetic ketamine for the treatment of mental health conditions has been found to frequently carry misleading or false information.

Exagamglogene autotemcel (Exa-Cel) was assigned a Prescription Drug User Fee Act action date of December 8, 2023, for the treatment of sickle cell disease.

Surge acted as a precursor for the RSV-marketed drug landscape in 2023, says GlobalData.

Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk, shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.