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Cipla gets FDA’s final approval for generic version of Migranal with CGT designation

Cipla gets FDA’s final approval for generic version of Migranal with CGT designation

Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the US Food and Drug Administration (FDA) with a competitive generic therapy (CGT) designation. The Indian pharma company said that it is the first approved applicant for such CGT and as a result is eligible for […]

Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay to be used for the molecular detection of COVID-19. According to the diagnostic healthcare products manufacturer, the EUA status enables the Lyra Direct SARS-CoV-2 Assay for carrying out direct sample processing without the extraction […]

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Deciphera gets Qinlock FDA approval for fourth-line advanced GIST

Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA) for Qinlock (ripretinib) in advanced gastrointestinal stromal tumor (GIST) in adult patients who had prior treatment with three or more kinase inhibitors, including imatinib. The decision from the FDA marks Qinlock as the first drug approved in […]

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Olympic Ophthalmics gets FDA clearance for iTEAR100 Neurostimulator

US medical technology company Olympic Ophthalmics has secured clearance from the US Food and Drug Administration for its iTEAR100 Neurostimulator. iTEAR100 is an external neurostimulator which has been granted a De Novo request by the FDA to temporarily increase acute tear production in adults by stimulating a cutaneous nerve. Dr Cynthia Matossian, an investigator in […]

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FDA rejects Blueprint’s NDA for AYVAKIT for treatment of fourth-line GIST

Blueprint Medicines said that the US Food and Drug Administration (FDA) has rejected its new drug application (NDA) for AYVAKIT (avapritinib) for the treatment of fourth-line gastrointestinal stromal tumor (GIST). The US precision therapy company received a complete response letter (CRL) from the FDA in this connection. Blueprint Medicines was seeking FDA approval for avapritinib […]

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Abbott gets FDA EUA for COVID-19 antibody blood test on Alinity i system

Abbott has been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG lab-based serology blood test, a COVID-19 antibody blood test, on the Alinity i system. The US medical device company will look to ship close to 30 million antibody tests across the world this world across […]

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Selpercatinib FDA approval : Lilly’s therapy approved for treatment of lung and thyroid cancers with RET alteration

Selpercatinib FDA approval : The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Retevmo (selpercatinib) capsules for the treatment of three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers. The approvals are for the drug to be used in patients whose tumors […]

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Lilly bags Retevmo FDA approval for RET-driven lung and thyroid cancers

Retevmo FDA approval : Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug Administration (FDA) for Retevmo (selpercatinib, 40mg and 80mg capsules) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Retevmo has also been approved by the FDA for the treatment […]

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Citius seeks FDA nod for evaluating stem cell therapy for ARDS in COVID-19

Citius Pharmaceuticals has made a Pre-IND submission to the US Food and Drug Administration for a novel stem cell therapy for acute respiratory distress syndrome (ARDS) in COVID-19 patients. In this regard, the late-stage specialty pharma company submitted a pre-IND meeting request and supporting briefing documents to the FDA’s Center for Biologics Evaluation and Research […]

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GS COVID-19RT-PCR diagnostic test : GenoSensor secures FDA EUA status

COVID-19 diagnostic test : GenoSensor has been granted emergency use authorization status from the US Food and Drug Administration (FDA) for its GS COVID-19 real-time reverse transcription-polymerase chain reaction (RT-PCR) diagnostic kit. According to the genomic technology company, the kit has been developed to generate accurate and reproducible quality results to help in clinical decision-making […]

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