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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 […]

Takeda gets extended EC approval for ADCETRIS in sALCL

Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients. The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a […]

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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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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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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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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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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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Incyte bags Pemazyre FDA approval for cholangiocarcinoma treatment

Pemazyre FDA approval : US biopharma company Incyte has bagged accelerated approval from the US Food and Drug Administration (FDA) for Pemazyre (pemigatinib) for the treatment of cholangiocarcinoma, a rare type of cancer occurring in the bile ducts. The approval is for adult patients having certain types of previously treated, advanced cholangiocarcinoma. According to the […]

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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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