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Articles for Regulatory

FDA Requests Additional Study For Amgen's Lumakras

Lumakras, an oral drug, is specifically designed to target a mutated form of the KRAS gene, occurring in approximately 13 per cent of non-small cell lung cancers, the most prevalent form of lung cancer, and less frequently in some other solid tumours

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FDA Seizes Counterfeit Ozempic: Thousands Of Fake Diabetes Drug Units Circulate, Health Warning Issued

Reportedly, Novo Nordisk, the manufacturer of Ozempic, is collaborating with the FDA to conduct testing on the seized counterfeit shots

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Lupin Secures USFDA Nod For Generic Chantix Tablets to Aid Smoking Cessation

Varenicline tablets, 0.5 mg, and 1 mg will serve as a generic equivalent to Chantix Tablets, 0.5 mg, and 1 mg which will be produced at Lupin's unit in Pithampur

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Health Canada Clears Novavax's Omicron-Targeted Vaccine For Children Above 12yrs

The World Health Organization (WHO) had previously granted emergency use authorisation for the vaccine last month, which is tailored to address a descendant of the XBB lineage of the coronavirus

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USFDA Hits Intas Pharmaceuticals With Another Warning Letter

The FDA has issued another warning letter to Intas Pharmaceuticals, citing manufacturing violations, quality control lapses, and compromised data integrity at its plant in Ahmedabad, Gujarat, India. The FDA has also added the Indian facility to its import alert list, allowing FDA field operatives to detain products from Intas without physical examination

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FDA's Proposed Changes To LDT Classification Stir Controversy Over Innovation & Patient Access

GlobalData's Device Approval Analyser Database indicates an average timeline of 5.9 years for test development in the US, while the approval process for devices takes eight to 13 months

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Eli Lilly's Jaypirca Secures FDA Approval For Chronic Lymphocytic Leukaemia Treatment

This latest endorsement by the FDA comes after the initial accelerated approval granted on January 27 for Jaypirca's efficacy in treating mantle cell lymphoma (MCL)

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NPPA Caps Prices On 9 Key Medications

Tacrolimus, an immunosuppressive medication crucial for minimising the risk of organ rejection post-transplant, is now priced at Rs 20.97 for 0.5 mg, Rs 39.98 for 1 mg, and Rs 77.69 for 2 mg. Additionally, the NPPA has fixed the ceiling price for Co-trimoxazole, a medication used to treat various bacterial infections, at Rs 2.30

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