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Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI

Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI

AstraZeneca has secured fast track designation for Farxiga (dapagliflozin) in the US for its use in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack. The fast track designation for the oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor is based on […]

Celltex Therapeutics gets FDA nod for Covid-19 stem cell clinical trial

Covid-19 stem cell clinical trial : Celltex Therapeutics has been given the clearance by the US Food and Drug Administration (FDA) to move ahead with a phase 2 clinical trial for investigating the efficacy of autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) in the prevention of Covid-19. In this connection, the Texas-based biotech company had […]

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Reneo Pharmaceuticals gets FDA ODD for REN001 in primary mitochondrial myopathies

Reneo Pharmaceuticals has been granted the orphan drug designation (ODD) for its lead drug candidate REN001 from the US Food and Drug Administration (FDA) for the treatment of primary mitochondrial myopathies (PMM). According to the California-based clinical-stage company, REN001 is a selective PPAR delta agonist, which is being developed for the treatment of genetic myopathies, […]

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Leap Therapeutics gets FDA orphan status for DKN-01 for gastric and gastroesophageal junction cancer

US immuno-oncology company Leap Therapeutics has been granted orphan drug designation for DKN-01 from the US Food and Drug Administration (FDA) for the treatment of gastric and gastroesophageal junction cancer. DKN-01, which is a humanized monoclonal antibody, has been designed to bind to and block the activity of the Dickkopf-1 (DKK1) protein, a modulator of […]

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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 […]

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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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