FDA committee backs approval of Sarepta Therapeutics’ SRP-9001 for DMD
Sarepta Therapeutics’ SRP-9001 (delandistrogene moxeparvovec) has received the backing of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) of the US Food and Drug ... Read More
Zydus Lifesciences gets FDA final approval for Sucralfate Tablets
Zydus Lifesciences has bagged final approval to manufacture and market Sucralfate Tablets USP, 1 gram from the US Food and Drug Administration (FDA). The approved ... Read More
EarlyTect BCD test : Promis Diagnostics gets FDA breakthrough designation
Promis Diagnostics has secured breakthrough device designation for its non-invasive EarlyTect BCD test from the US Food and Drug Administration (FDA) as a urine-based diagnosis ... Read More
Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia
Teva Pharmaceuticals and MedinCell have bagged approval for UZEDY (risperidone) extended-release injectable suspension from the US Food and Drug Administration (FDA) for schizophrenia treatment in ... Read More
Zydus Lifesciences wins FDA final approval for Isoproterenol HCL injection
Zydus Lifesciences has secured final approval for Isoproterenol Hydrochloride (HCL) Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials from the US ... Read More
Zydus Lifesciences bags FDA final approval for Tavaborole Topical Solution
Zydus Lifesciences has won final approval from the US Food and Drug Administration (FDA) for Tavaborole Topical Solution, 5%. The approved product is a generic ... Read More
Emergent’s Narcan nasal spray receives OTC nod for opioid overdose treatment
Emergent BioSolutions’ Narcan nasal spray has secured over-the-counter (OTC) designation from the US Food and Drug Administration (FDA), becoming the first and only prescription strength ... Read More
Lupin bags tentative approval for Ocaliva Tablets generic in US
Lupin said that it has been issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg from the US Food and Drug Administration ... Read More
Lupin partner Caplin Steriles gets FDA nod for Zemuron Bromide generic
Lupin Limited said that its alliance partner Caplin Steriles has won final approval for Rocuronium Bromide Injection, 10mg/mL in 5 mL and 10 mL multi-dose ... Read More
Glenmark Pharmaceuticals set to begin clinical trial of GRC 54276 in US
Glenmark Pharmaceuticals, through its subsidiary Glenmark Specialty, is set to begin a first-in-human, phase 1/2 clinical study of GRC 54276 in the US for the ... Read More