FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The Biden administration has—for the second time—delayed the decision on a proposed FDA rule that would ban menthol cigarettes and all flavors in cigars.
FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
Sylvester’s C. Ola Landgren: “I was convinced that this is really the way to go”
FDA has approved ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
FDA revised a draft guidance to answer questions that biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars.
FDA Center for Drug Evaluation and Research is soliciting grant applications from independent organizations to support meetings that bring together a broad range of stakeholders to explore, research, and address issues related to medical products, policy, and surveillance methods and systems.
FDA approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.
