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CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024
Response addresses all issuespreviously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels
Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialization of neffy. ARS Pharmaceutica...
>>> Read more: ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization Application to EMAâs CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand
Response addresses all issuespreviously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels
Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialization of neffy. ARS Pharmaceutica...
>>> Read more: ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization Application to EMAâs CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand