Provention Bio is resubmitting a Biologics License Application (BLA) for teplizumab, a drug intended to delay the onset of Type 1 diabetes (T1D) in at-risk individuals, following a Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration.

Regeneron Pharmaceuticals and the company’s partner Sanofi voluntarily withdrew their application with the U.S. drug regulator for the expanded use of the anti-cancer drug Libtayo in patients with advanced cervical cancer.

While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.

After a U.S. District Court judge ruled that the U.S. Food and Drug Administration must begin disclosing data surrounding the approval of COVID-19 vaccines within a span of eight months, Pfizer hopes to step in to ensure that no trade secrets are disclosed when the regulatory agency begins to share that information.

South San Francisco-based Cortexyme Inc. received a letter from the U.S. Food and Drug Administration on January 25 placing a full clinical hold on the Investigational New Drug application for the company’s lead clinical asset atuzaginstat, which is in development for the treatment of Alzheimer’s disease.

Incyte Corporation withdrew the New Drug Application (NDA) for the company’s candidate drug for various types of lymphoma.

The U.S. Food and Drug Administration approved Immunocore’s Kimmtrak (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). 

Gilead

The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.

The U.S. Food and Drug Administration granted Emergency Use Authorization for Mammoth Biosciences Inc.’s DETECTR BOOST SARS-CoV-2 Reagent Kit, a first of its kind high-throughput solution that combines the power of CRISPR with laboratory automation for SARS-CoV-2 testing.

TScan Therapeutics secured clearance from the U.S. Food and Drug Administration for the company’s investigational new drug application to assess TSC-100 in treating patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).