Dizal Pharmaceutical has obtained breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its sunvozertinib for the first-line treatment of individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).
Everest Medicines has announced plans to terminate its partnership and licence agreements with Providence Therapeutics for the development of products using its mRNA platform.
Precision BioSciences has received upfront cash payment and equity investment totalling $17.5m from TG Therapeutics for an exclusive licence to develop Azercabtagene Zapreleucel (azer-cel).
Aizon, an artificial intelligence (AI) Software as a Service (SaaS) provider for pharmaceutical manufacturing operations, has secured $20m in Series C funding to expedite its development pipeline.
The US National Institutes of Health (NIH) unit National Institute on Drug Abuse (NIDA) has granted an award of $9m for researchers to advance drug, SBP-9330, to treat nicotine addiction.
Oricell Therapeutics has announced the clearance of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for OriCAR-017, a new CAR-T cell therapy targeting GPRC5D, for the treatment of relapsed/refractory multiple myeloma (R/R MM).
The Progeria Research Foundation (PRF) has announced the Japanese approval of Zokinvy (lonafarnib) for treating Progeria and processing-deficient Progeroid Laminopathies (PL).
Chinese biotechnology company GenFleet Therapeutics has received the US Food and Drug Administration (FDA) designations for its drug candidate SLS009 (GFH009).
AGC Biologics has announced the establishment of a new manufacturing site at the AGC Yokohama Technical Center in Japan.
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