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Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
With the Thanksgiving season upon us, there are many reasons for biopharma and life sciences companies to say thanks, including for new leaders.
Editas Medicine is pausing its ocular gene therapy program after demonstrating a favorable safety profile and seeking a potential partner to develop EDIT-101, the company announced Thursday.
Regeneron and CytomX Therapeutics inked a deal valued at up to $2 billion to develop next-generation bispecific immunotherapies for cancer, the companies announced Thursday.
GSK has pulled out of its partnership focused on developing T-cell receptor therapeutics for solid tumors with Immatics, the German biotech revealed in its Q3 financial results published Thursday.
Alloy Therapeutics inked an antibody discovery deal with Normunity Thursday to advance the latter’s immune normalizers, antibody therapies that boost the body’s natural immune system to fight cancer.
Astellas’ Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.
The FDA has requested that Clovis Oncology limit the indication of its PARP inhibitor Rubraca as second-line maintenance therapy in recurrent ovarian cancer.
New research out of McMaster University found a recently abandoned Bayer compound halted the growth of an aggressive form of pediatric medulloblastoma in mouse models.
Ardelyx has moved one step closer to the possible approval of its experimental chronic kidney disease drug tenapanor following a favorable 9-4 vote from an FDA advisory committee.
Huntington’s disease might just top the list of intractable neurodegenerative diseases. BioSpace spoke with the field’s foremost experts about the challenges and how to overcome them.