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Articles for Regulatory

Zydus's Sugammadex Gets Final Nod From USFDA

Zydus's Sugammadex Injection indicated for the reversal of neuromuscular blockade gets final approval from USFDA.

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USFDA Accepts Sun Pharma's NDA For Deuruxolitinib

U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Sun Pharma's deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata.

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Indian Regulator Finds More Toxic Syrups

India's drug regulator has found that a cough syrup and an anti-allergy syrup made by Norris Medicines are toxic, according to a government report, months after Indian-made cough syrups were linked to 141 children's deaths worldwide

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Strides Receives Clearance For HIV Drugs From USFDA

EET tablets belong to a class of medication known as antiretrovirals and this fixed-dose triple-drug combination medication is indicated for treatment of HIV-1 infection in adult patients weighing at least 40kgs. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla Tablets of Gilead Sciences LLC.

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Strides’s Icosapent Ethyl Capsules Get Approval From USFDA

Icosapent Ethyl Capsules can be used as a dietary adjunct for lowering triglyceride (TG) levels in adult patients with severe hypertriglyceridemia

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SigTuple's AI Assisted Digital Microscopy Device Gets Nod From USFDA

SigTuple’s AI100 with Shonit is AI-assisted digital pathology, wherein a physical sample is digitally imaged through a microscopic lens and the AI models extract each cell and then classify it into over 30 different cell types

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FDA Approves First DNA Test For Assessing Predisposition To Dozens of Cancer Types

U.S. Food and Drug Administration granted novel market authorisation for Invitae Common Hereditary Cancers Panel.

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NPPA Sets Retail Prices For 51 Critical Drugs

The National Pharmaceutical Pricing Authority (NPPA) has established ceiling prices for 51 drug formulations, including medications such as Sitagliptin, Pioglitazone, and Metformin Hydrochloride (Sustained Released) Tablets used in the management of type 2 diabetes mellitus.

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