The US Food and Drug Administration (FDA) has granted Fast Track Designation to Adicet Bio's ADI-270, a potential treatment for patients suffering with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have received treatment with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
The European Commission has approved AstraZeneca's Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
Alembic Pharmaceuticals has announced its tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) submitted for Ivosidenib Tablets, 250mg.
The US Food and Drug Administration (FDA) has granted fast track designation for radiotherapeutics company Full-Life Technologies’ 225Ac-FL-020 to treat metastatic castration-resistant prostate cancer (mCRPC).
Tubulis has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead antibody-drug conjugate (ADC), TUB-040, aimed at treating patients with platinum-resistant ovarian cancer.
UK-based Yellowstone Biosciences has announced its launch with a £16.5m investment from Syncona to develop soluble bispecific T-cell receptor (TCR)-based therapies.
Clinical-stage biotechnology company Iambic Therapeutics has secured $50m in its Series B extension financing round to bolster its pipeline comprising artificial intelligence (AI)-discovered clinical oncology programmes.
Takeda has entered into an option agreement with Ascentage Pharma, securing the opportunity to obtain exclusive global licensing rights for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI).
Sibylla Biotech has entered into a strategic partnership with The University of Texas MD Anderson Cancer Center to advance the development of new cancer therapies.
Repare Therapeutics has received Fast Track designation from the US Food and Drug Administration (FDA) for lunresertib in combination with camonsertib to treat adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer.
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