Tag: USFDA
The US FDA designates Intellia’s NTLA-2002, a regenerative medicine advanced therapy to treat hereditary angioedema.
The US Food and Drug Administration (FDA) has designated NTLA-2002 for the treatment of hereditary angioedema as a…
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…
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…
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…
The US FDA committee votes in favour of the favourable benefit-risk profile of Paxlovid from Pfizer’s.
According to a report from Pfizer Inc., the Antimicrobial Drugs Advisory Committee (AMDAC) of the US Food and…
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…
Zydus receives final approval from the USFDA for Lenalidomide Capsules, 2.5 mg and 20 mg
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United…
The USFDA has given approval for fluorouracil injection, a cancer medication, to Alembic Pharma.
Alembic Pharmaceuticals Ltd (Alembic) declared that its Abbreviated New Drug Application (ANDA) fluorouracil injection USP, 2.5 g/50 mL…
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…
The US FDA has authorised COVI-Go, a COvid-19 fast antigen self-test, for emergency use at home.
Mologic Inc., a leading provider of lateral flow and quick diagnostic technologies, products, and services, disclosed that the…
