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The US Food and Drug Administration (FDA) has designated NTLA-2002 for the treatment of hereditary angioedema as a Regenerative Medicine Advanced Treatment (RMAT), according to Intellia Therapeutics, Inc., a leading clinical-stage genome editing business (HAE). NTLA-2002 is a CRISPR-based in…
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.,…
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…
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…
According to a report from Pfizer Inc., the Antimicrobial Drugs Advisory Committee (AMDAC) of the US Food and Drug Administration (FDA) voted 16 to 1 in favour of the safety and efficacy of Paxlovid (nirmatrelvir and ritonavir tablets) for the…
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…
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Lenalidomide Capsules, 2.5 mg and 20 mg (USRLD: Revlimid® Capsules). Lenalidomide Capsules are used to…
Alembic Pharmaceuticals Ltd (Alembic) declared that its Abbreviated New Drug Application (ANDA) fluorouracil injection USP, 2.5 g/50 mL (50 mg/mL) pharmacy bulk vial has been given final FDA approval. The reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL…
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…
Mologic Inc., a leading provider of lateral flow and quick diagnostic technologies, products, and services, disclosed that the US Food and Drug Administration (FDA) had granted emergency use approval (EUA) for its proprietary COVI-Go SARS-CoV-2 Ag Self-Test for over-the-counter use…
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