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news.March Bio’s MB‑105 gains FDA RMAT for CD5+ T‑cell lymphoma
The RMAT designation was based on initial data from March Bio’s ongoing multi-centre Phase II clinical trial, which indicated clinical activity and a manageable safety profile in a
The RMAT designation was based on initial data from March Bio’s ongoing multi-centre Phase II clinical trial, which indicated clinical activity and a manageable safety profile in a
The new site increases capacity and strengthens the company’s supply chain capabilities for RLTs in the US. The facility in Carlsbad, filed with the US Food and Drug
These candidates will be developed using SanegeneBio’s tissue-selective ligand and enhancer assisted delivery (LEAD) technology. The partnership focuses on advancing new therapies that can potentially be administered subcutaneously
The authorisations are granted for Gobivaz in 50 mg/0.5 mL and 100 mg/mL formulations, available in pre-filled syringes and autoinjectors. The medication is indicated for the treatment of
The designation highlights the considerable unmet medical needs of patients with AML and recognises LTI-214’s therapeutic potential as a new treatment for this aggressive form of blood cancer.