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FDA grants priority review for Nefecon, for patients with IgA nephropathy

FDA grants priority review for Nefecon, for patients with IgA nephropathy Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ( Calliditas ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.) The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. We are very excited about being granted priority review, which reflects the unmet medical need of IgAN. We look forward to engaging with the agency and work towards an accelerated approval later this year so that we will be in a position to provide the first approved medication for IgAN patients, said CEO Renée Aguiar-Lucander.

United statesKostenloser wertpapierhandelAndrew udellMarie galayExchange commissionDrug administrationNasdaq stockholmPriority reviewNew drug applicationPrescription drug user fee actNorth america commercial andrewNasdaq global select marketPrivate securities litigation reform actஒன்றுபட்டது மாநிலங்களில்ஆண்ட்ரூ ஊடேல்ல்பரிமாற்றம் தரகு

DBV Technologies S A : Ordinary and Extraordinary General Meeting of May 19, 2021 to be Held in Closed Virtual Session Due to COVID-19 Pandemic

DBV Technologies S A : Ordinary and Extraordinary General Meeting of May 19, 2021 to be Held in Closed Virtual Session Due to COVID-19 Pandemic
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New yorkUnited statesFrance generalPierre brossoletteAnne pollakAngela marcucciSociete generale securities servicesCompany adssBoard of directors the companyExtraordinary general meetingClosed virtual session dueNasdaq stock marketGeneral meetingsGeneral meetingObtaining preparatory documentsLegal gazette

NANOBIOTIX to Present Four Posters Including Updates From Priority Head and Neck Cancer and Immunotherapy Development Pathways at the 2021 Annual Meeting of the American Society for Clinical Oncology

(1) New data with additional patients and further follow up from Study 1100, evaluating lead product candidate NBTXR3 in combination with anti-PD-1 in head and neck cancer, lung metastasis and/or liver metastasis New data with additional patients and further follow up on safety and response rate from Study 102 dose expansion, evaluating NBTXR3 as a single agent activated by radiotherapy in head and neck cancer Long term safety data from complete European phase II/III registration study, Act.In.Sarc, evaluating NBTXR3 as a single agent activated by radiotherapy in soft tissue sarcoma From bench-to-bedside compilation data encompassing the journey of NBTXR3 from preclinical investigation to clinical evaluation of NBTXR3 as a potentially tumor-agnostic radioenhancer that could prime adaptive immune response for both local and systemic control

United statesFrance generalUnited kingdomBrandon owensKate mcneilPorter novelliPierre louis germainExchange commission onFrench financial markets authority autoritCommunications departmentAmerican society of clinical oncologyUniversity of texas md anderson cancer centerInvestor relations departmentDrug administrationDiagnostic developmentGiven the company

FDA grants priority review for Nefecon, for patients with IgA nephropathy

FDA grants priority review for Nefecon, for patients with IgA nephropathy
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United statesAndrew udellMarie galayDrug administrationNasdaq stockholmPriority reviewNew drug applicationPrescription drug user fee actNorth america commercial andrewNasdaq global select marketஒன்றுபட்டது மாநிலங்களில்ஆண்ட்ரூ ஊடேல்ல்நாஸ்டாக் ஸ்டாக்‌ஹோல்ம்ப்ரையாரிடீ விமர்சனம்புதியது மருந்து விண்ணப்பம்ப்ரிஸ்க்ரிப்ஶந் மருந்து பயனர் கட்டணம் நாடகம்

FDA grants priority review for Nefecon, for patients with IgA nephropathy

FDA grants priority review for Nefecon, for patients with IgA nephropathy
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United statesAndrew udellMarie galayExchange commissionDrug administrationNasdaq stockholmPriority reviewNew drug applicationPrescription drug user fee actNorth america commercial andrewNasdaq global select marketPrivate securities litigation reform actஒன்றுபட்டது மாநிலங்களில்ஆண்ட்ரூ ஊடேல்ல்பரிமாற்றம் தரகுநாஸ்டாக் ஸ்டாக்‌ஹோல்ம்