Regulatory

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.

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.

Multiple regulatory pathways exist during the drug development process.

Klein discusses how recent FDA draft guidelines will impact the use of SaMD in the life sciences industry.

The proposed rule is aimed at ensuring the safety and effectiveness of the tests.

The program will offer participants more opportunity to communicate with FDA staff.

Lakdawalla speaks about how drugs aren’t being properly valued.

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

Cleve talks about the future of the industry and how data remains a key focus.

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

Drug access leads list of issues raised by pharma shareholders.

Workshop on pharma M&A review and enforcement focuses on what’s not working and what should be on the chopping block.

In this exclusive Q&A, Alice Valder Curran, life sciences regulatory expert and partner, Hogan Lovells LLP, shares her perspective on the biggest drug pricing challenges today, current efforts to lower drug pricing, and the Inflation Reduction Act.

Frederique Welgryn, global vice president for women's health, Perrigo, shares insight into the approval of Opill (norgestrel), a progestin-only contraception, in this exclusive Q&A.