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Articles for Regulatory

FDA Warns of Probiotic Product Risks in Premature Infants

These products, which are meant to supplement regular feeding and contain live organisms like bacteria or yeast, have the potential to cause invasive and possibly fatal infections or diseases, as stated by the FDA

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DCGI Approves MSD India’s Drug Keytruda For Triple Negative Breast Cancer

With this approval, Keytruda is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma and early-stage triple-negative breast cancer

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Zydus Receives Approval For ALS Phase II Trial Of ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor that is highly potent in human whole blood assay and can suppress inflammation caused by the NLRP3 inflammasome

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FDA Reviews AstraZeneca's Self-administered FluMist Quadrivalent

The application pertains to the approval of their nasal flu vaccine for administration by patients or caregivers

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Lupin Receives FDA Approval For Generic Fluconazole Tablets

The Abbreviated New Drug Application for Fluconazole Tablets will be manufactured at Lupin’s Pithampur facility in India.

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USFDA Expands Anti Cancer Drug Entrectinib Indication For Pediatric Patients

This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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Indoco Remedies Stock Slides 3% As Goa Facility Gets Four Observations From USFDA

Indoco Remedies, an Indian pharmaceutical company on Thursday notified the exchanges that its solid oral formulation facility located at Goa was inspected by the United States Food and Drug Administration (USFDA) ) from October 12, 2023, to October 18, 2023

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DeepTek.ai Receives FDA Clearance For Chest X-ray AI

Chest X-ray AI solution -CXR Analyser, uses deep learning algorithms to detect abnormalities in chest X-rays to identify, categorise, and highlight suspicious areas automatically, aiding clinicians in making precise interpretations.

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