Tag: USFDA

To treat patients with solid tumours, Sensei Biotherapeutics has submitted an IND application to the US FDA for a phase 1/2 trial of SNS-101.

An investigational new drug (IND) application for SNS-101, a conditionally active VISTA-blocking antibody, has been submitted to the US Food and Drug Administration (FDA) for a phase 1/2 clinical trial in patients with solid tumours, according to Sensei Biotherapeutics, Inc.,…

For the treatment of pancreatic cancer, the US FDA has given Prestige Biopharma’s PBP1510 fast track designation.

The US Food and Drug Administration (FDA) has granted PBP1510 (international non-proprietary name: ulenistamab), a biopharmaceutical product manufactured by Singapore-based Prestige Biopharma, Fast Track designation for the treatment of metastatic or unresectable pancreatic adenocarcinoma (PDAC) that has relapsed after and/or…

Kuria Therapeutics ने कॉर्नियल एंडोथेलियल disease के लिए topical Nrf2 activator के लिए USFDA Pre-IND परामर्श पूरा किया

The FDA provided encouraging input on Kuria Therapeutics’ development plan for KTX-1161 for corneal endothelial dysfunction during a pre-Investigational New Drug (IND) interaction, according to the pharmaceutical company, which is working on innovative ophthalmic and dermal treatments. A topical ophthalmic…

Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg

BRIDGEWATER, N.J.–(BUSINESS WIRE)– Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and…

Laevoroc’s LR 09 is given orphan medication classification by the US FDA to treat leukaemia relapse following allogeneic stem cell transplant.

LR 09, a novel metabolic immune checkpoint inhibitor, has been given Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of patients with haematological malignancies who have been identified with a relapse following allogeneic stem…

Once-weekly Altuviiio, a new kind of factor VIII therapy for haemophilia A that provides considerable bleed prevention, has been approved by the US FDA.

Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], formerly known as efanesoctocog alfa, is a first-in-class, highly sustained factor VIII replacement therapy that has received FDA approval. For both adults and children with haemophilia A, the use of altuviiio is recommended…

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