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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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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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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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FDA grants EUA for Gilead’s investigational COVID-19 drug remdesivir

Remdesivir EUA status : The US has officially pushed the use of remdesivir for treating the novel coronavirus with the Food and Drug Administration (FDA) granting emergency use authorization (EUA) to the investigational COVID-19 drug candidate being developed by Gilead Sciences. The EUA lets the antiviral drug candidate to be used for the treatment of […]

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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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Actemra coronavirus clinical trial : Genentech gets FDA nod for COVID-19 trial

Actemra coronavirus clinical trial : Genentech has been given approval by the US Food & Drug Administration (FDA) to undertake the phase 3 COVACTA trial to assess the safety and efficacy of intravenous Actemra (tocilizumab) along with standard of care in hospitalized adults having severe COVID-19 pneumonia. The Roche subsidiary will carry out the randomized, […]

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Gilead Sciences bags Epclusa FDA approval for hepatitis C in pediatric patients

Epclusa FDA approval : Gilead Sciences has secured an expanded approval for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) from the US Food and Drug Administration (FDA), which covers treatment of chronic hepatitis C infection (HCV) in children. The approval is for the drug to be used for the treatment of children aged six […]

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FDA approves Opdivo + Yervoy for HCC previously treated with sorafenib

Bristol Myers Squibb has secured approval for the combination of Opdivo (nivolumab) 1 mg/kg and Yervoy (ipilimumab) 3 mg/kg from the US Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC) in patients who were previously treated with sorafenib. Approval for the indication has been issued under accelerated approval on the basis […]

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Olympus secures FDA clearance for TJF-Q190V duodenoscope

Olympus Medical Systems Group has secured clearance from the US Food and Drug Administration (FDA) for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The latest generation duodenoscope from Olympus is said to have integrated advanced features to enhance cleaning and reprocessing of the endoscopy instrument, in order to help in reducing potential device […]

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