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February 21, 2024
Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.
Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.
Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.
February 20, 2024
The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.
FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.
February 19, 2024
Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.
Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.
The partnership revolves around meeting various agency standards and industry requirements pertaining to the drug development and manufacturing lifecycle.
February 16, 2024
Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.
Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.